Premier Research
A global clinical research organization.We’re out to change the course of medical science. Are you ready to rise to the challenge? Premier Research is not about being everything to everyone. Instead, our deep, focused expertise targets the therapeutic areas and indications where today’s biotech and specialty pharma pioneers are doing the most amazing work. We’re 1,500 employees strong and operate in more than 20 countries, delivering unmatched expertise, operational skills, and dedication to meeting customers’ most challenging needs.
Headquarter Location:
Morrisville, North Carolina, USA
Premier Research is hiring a Remote Site Start up Associate I- Bangalore-Office Based
Description
Premier Research is looking for a Site Start Up Associate 1 to join the SSU Team in India. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What You’ll Be Doing:
- Takes responsibility for quality deliverables at the country level for study start-up
- Follows project requirements and applicable country rules.
- Proactively forecasts submission/approval timelines and ensures they are adhered to. If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified.
- May serve as the primary point of contact for the Project Manager, Clinical Manager, Regulatory Start-up Manager (or designee) during start-up on allocated projects.
- Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
- Prepares ongoing submissions, amendments, and periodic notifications (including safety reporting) required by central and local EC and RA, and other local regulatory authorities as needed within the country, as required by local rules. Submits end of study notifications to RA, ECs/IRBs and other local authorities in the specified country according to national timelines.
- Performs essential document collection and review, ensuring that sponsor and investigator requirements are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Prepares Investigational Product (IP) checklist according to country regulations.
- Ensures accuracy and completeness of Trial Master File documents submitted throughout the study and performs a QC review of files for which Start-up Associate is acting as document owner, in line with the requirements set in the File Management Plan.
What We Are Searching For:
- Provides all regulatory documents and relevant study correspondence along with translations to the Clinical Research Associate throughout the study conduct.
- Collects information on submission deadlines and timeline metrics for RAs, ECs, IRBs and other local bodies as appropriate.
- Liaises with internal team members to review areas that impact study start-up and shares start-up information with the project team.
- Sets up and maintains a country folder with country ECs/IRBs and local authority addresses and requirements, as required.
- Provides quality review of the informed consent and adapts the template as appropriate, as well as other patient documents, or specific documentation that is required in the country.
- Works within the scope of Regulatory Start Up plan (RSSP), study processes, applicable regulations, ICH-GCP and/or ISO14155 and any other requirements mandated by the study
- Enters and maintains trial status information relating to SSU activities into Premier’s tracking databases, in an accurate and timely manner.
- Ensures documentation of QC of eTMF within the scope of File Management Plan (FMP) from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client.
- Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.
- Performs other duties as required
Why Choose Premier Research?
• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
See more jobs at Premier Research
Premier Research is hiring a Remote Associate Director, Finance - India, Bangalore based
Description
Premier Research is looking for anAssociate Director to join ourFinanceteam. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You.We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You.As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechTM.Join us and build your future here.
What You’ll Be Doing:
The Associate Director, Financewill be responsible for Financial Accounting and Financial Reporting, ensuring the financial integrity and external reporting responsibility for the results of India.
- Coordinates and manages month/quarter/year-end financial close for assigned entities including balance sheet, income statements and cash flow using United States Generally Accepted Accounting Principles, IFRS and/or other local statutory accounting rules.
- Manages all phases of financial audits for assigned jurisdictions statutory audits as well as participates in the US consolidated annual audit.
- Ensures all tax returns including Corporate Income Tax, Value Added Tax, and others for assigned jurisdictions are submitted accurately and timely.
- Ensures all statutory filings and compliance filings are completed in a timely manner and within government guidelines.
- Manages R&D Tax Credit submissions and collections of funds where applicable.
- Manages and mentors assigned staff to enhance company efficiencies and personal development.
What We Are Searching For:
- Undergraduate degree or its international equivalent in financial, business or scientific related field from an accredited institution or relevant work experience
- A recognized professional accounting qualification e.g. CPA/ICAEW/CIMA/ACCA
- Minimum 8 years progressive financial management experience
- Minimum of 6 years supervisory/management experience
- Second language is not essential though fluent verbal and written English is a must.
- Knowledge of US and IFRS Generally Accepted Accounting Practice
Why Choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (contractor)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Associate Data Coordinator
Description
Premier Research is looking for an Associate Data Coordinatorto join our Clinical Data Sciences team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech. Join us and build your future here.
Ensures the successful and accurate transfer of clinical trial data from laboratories and other clinical data providers to a Clinical Data Management System (CDMS) or other data repository. Receives electronic data files containing clinical trial data from external data provider and conducts data preparation steps to ensure the data is ready for processing. Loads processed data into CDMS or other data repository.
Troubleshoots data load and processing errors and liaises with study teams and data providers to resolve issues. Serves as the point of contact for electronic data inquiries from data providers and study teams.
What you’ll be doing:
- Assists in the preparation of documentation, such as CCGs, DMP, Data Report Specifications, External Data Transfer Specifications, etc.
- Supports UAT on studies, including testing of edit checks, etc.
- Assists in maintaining databases and supports DB updates
- Performs data entry
- Generates reports for data review
- Reviews CRFs, data listings to ensure all data captured follow protocol, CCGs, DMP, etc.
- Generates queries to appropriate internal or external personnel (e.g., investigational sites, Clinical Research Associates and client representatives) to resolve problematic data identified during various aspects of the data management process
- Reviews responses to queries and resolves discrepancies
- Assists with external data and/or serious adverse event reconciliation
- May act as a Lead Data Coordinator or Safety Reviewer
- Assists document submission to Trial Master File (TMF)
- Supports TMF Quality Control (QC) activities and database QC activities, QC of study reports, CRF archive files
- Supports the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, project status
Requirements:
- Bachelor’s Degree or above (preferably in a Life Science)
- Typically requires 0 -1 year industry experience
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly
care about one another, about our clients, and about our mission of furthering
research to improve the lives of patients in critical need. - Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
- Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are
excited about this role, but your past experiences do not perfectly align with the position as
described, we encourage you to apply anyway. You may be exactly the right candidate for this
role or others.
excited about this role, but your past experiences do not perfectly align with the position as
described, we encourage you to apply anyway. You may be exactly the right candidate for this
role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Project Manager - Neuroscience
Description
We’re looking for a Senior Project Manager to join our Neuroscience team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
This role requires evidence of really strong recent CNS expertise and experience in managing CNS vendors.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You.Your ideas influence the way we work, and your voice matters here.
- We are Built with You.As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
- Adherence to project budget and scope of work to realize project profitability
- Project risks identification and mitigation
- Effective communication, and project status reports and monthly progress reports are provided both internally and externally
- Adequate resourcing to meet project deliverables and milestones
- Representation at client meetings along with commercial colleagues to help win new business
You’ll need this to be considered:
- Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education
- 6 years relevant experience, preferably in a CRO, including 5 years of clinical project management, preferably in a CRO
- 3 years of experience in managing progressively large and complex scientific research projects, at least half of which has been in a matrix environment
- Experience in the Neuroscience area is essential
- Strong budget/finance experience on a project level
- Demonstrated understanding of therapeutic and protocol disciplines in Neuroscience, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
- Willingness to travel
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-JD1
#Remote
#LI-JD1
#Remote
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Project Manager, Cell and Gene Therapy
Description
Premier Research is looking for a Senior Project Manager to join our Cell & Gene Therapy team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Ensures successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
- Maintains and evaluates study progress by using company tracking systems, project timelines and budget reviews and projecting profitability
- Manages the project team to ensure study progress is according to both client and Premier Research requirements and in compliance with standard Premier Research processes, policies and procedures
- Ensures effective communication is maintained and project status reports and monthly progress reports are provided both internally and externally
- Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
- Prepares forecasts for staff utilization over the life of the study and ensures adequate resourcing is available to meet project deliverables and milestones
What we are searching for in a Senior Project Manager:
- Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
- 8 years of clinical research experience
- 5 years of project management experience, preferably with a CRO
- Experience working globally
- Experience in Cell and Gene Therapy
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and most importantly about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly.
Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.
#LI-CI1
See more jobs at Premier Research
Premier Research is hiring a Remote TMF Lead I
Description
Premier Research is looking for a TML Lead I to join our Global Records Management team. You will help biotech, MedTech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM .Join us and build your future here.
What you’ll be doing:
- Ensures personal utilization targets and study performance metrics are met
- Acts as primary point of contact for project teams, Sponsors, auditors and other external third parties on assigned studies/programs
- Supervises department team on assigned studies/programs as needed
- Ensures performance metrics are met and scope of work is performed according to budgets and timelines for assigned studies/programs for supervised staff as required
- Ensures that any out-of-scope activities are identified, reported to department management, itemized with project leadership and appropriately budgeted in change orders for assigned studies/programs
- Leads and/or assists management with department continuous improvement activities globally
- Supervises the security, environment and access control of Secure File Room (SFR) facilities located in their local office or region (if applicable)
- Oversees Project Team compliance to essential document management requirements, TMF SOPs and TMF Plans for assigned studies/programs and supervised staff
- Provides mentoring and training of new hires, project teams and external staff as needed
- Performs all departmental budgeted activities for assigned studies/programs
- Assists management with candidate review, interviews, hiring recommendations,
- Assists with on-boarding and training of department staff globally
- Serves as primary point of contact for programs and providing program level customer service and support for key Sponsor relationships
- Participates in business development presentations and system demonstrations, study KOMs and other targeted project team meetings globally as needed
- Performs eTMF System Administrator responsibilities as needed
What We Are Searching For:
- Undergraduate degree or international equivalent from an accredited institution majoring in records and information management, library science, clinical, science or health related field required - or – an equivalent level of clinical trials records management experience.
- 6+ years (of clinical trials essential document management and/or records management experience is required.
- Significant experience using computerized clinical trials records management technologies is required.
- Project, clinical and/or quality management experience preferred.
- Significant knowledge of ICH-GCP, ISO14155 and global regulations pertaining to essential document management and Trial Master File management is required.
Why Choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Project Manager II
Description
Premier Research is looking for aProject Manager II to join ourOncology team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You.We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You.Your ideas influence the way we work, and your voice matters here.
- We are Built with You.As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM.Join us and build your future here.
You'll be accountable for:
- Successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
- Adherence to project budget and scope of work to realize project profitability
- All project tasks completion in accordance with project plans and in compliance with global and consistent Premier Research processes, policies, and procedures
- Project risks identification and mitigation
- Effective communication, and project status reports and monthly progress reports are provided both internally and externally
- Compliance for project-related training
- Adequate resourcing to meet project deliverables and milestones
- Representation at client meetings along with commercial colleagues to help win new business
As a PM II you will need to be creative, delivery focused, and require:
- Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
- 6 years relevant experience, preferably in a CRO/pharmaceutical company/medical device company, including 2 years of clinical project management or clinical management experience
- 3 years of experience in managing progressively large and complex scientific research projects, at least half of which has been in a matrix environment
- Strong budget/finance experience on a project level
- Demonstrated understanding of therapeutic and protocol disciplines in Oncology, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
- Able to lead and motivate team members
- Skilled at multitasking and working effectively in a fast-paced environment with competing priorities to meet deadline, and address problems decisively and objectively
- A highly confident and effective presenter, fluent in English with strong oral and written communication skills and proficiency with web-based communication tools
- Willingness to travel
Why choose Premier?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Spain)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote TMF Lead I - Poland
Description
Premier Research is looking for a TML Lead I to join our Global Records Management team. You will help biotech, MedTech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM .Join us and build your future here.
What you’ll be doing:
- Ensures personal utilization targets and study performance metrics are met
- Acts as primary point of contact for project teams, Sponsors, auditors and other external third parties on assigned studies/programs
- Supervises department team on assigned studies/programs as needed
- Ensures performance metrics are met and scope of work is performed according to budgets and timelines for assigned studies/programs for supervised staff as required
- Ensures that any out-of-scope activities are identified, reported to department management, itemized with project leadership and appropriately budgeted in change orders for assigned studies/programs
- Leads and/or assists management with department continuous improvement activities globally
- Supervises the security, environment and access control of Secure File Room (SFR) facilities located in their local office or region (if applicable)
- Oversees Project Team compliance to essential document management requirements, TMF SOPs and TMF Plans for assigned studies/programs and supervised staff
- Provides mentoring and training of new hires, project teams and external staff as needed
- Performs all departmental budgeted activities for assigned studies/programs
- Assists management with candidate review, interviews, hiring recommendations,
- Assists with on-boarding and training of department staff globally
- Serves as primary point of contact for programs and providing program level customer service and support for key Sponsor relationships
- Participates in business development presentations and system demonstrations, study KOMs and other targeted project team meetings globally as needed
- Performs eTMF System Administrator responsibilities as needed
What We Are Searching For:
- Undergraduate degree or international equivalent from an accredited institution majoring in records and information management, library science, clinical, science or health related field required - or – an equivalent level of clinical trials records management experience.
- 6+ years (of clinical trials essential document management and/or records management experience is required.
- Significant experience using computerized clinical trials records management technologies is required.
- Project, clinical and/or quality management experience preferred.
- Significant knowledge of ICH-GCP, ISO14155 and global regulations pertaining to essential document management and Trial Master File management is required.
Why Choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote TMF Lead I - Bulgaria
Description
Premier Research is looking for a TML Lead I to join our Global Records Management team. You will help biotech, MedTech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM .Join us and build your future here.
What you’ll be doing:
- Ensures personal utilization targets and study performance metrics are met
- Acts as primary point of contact for project teams, Sponsors, auditors and other external third parties on assigned studies/programs
- Supervises department team on assigned studies/programs as needed
- Ensures performance metrics are met and scope of work is performed according to budgets and timelines for assigned studies/programs for supervised staff as required
- Ensures that any out-of-scope activities are identified, reported to department management, itemized with project leadership and appropriately budgeted in change orders for assigned studies/programs
- Leads and/or assists management with department continuous improvement activities globally
- Supervises the security, environment and access control of Secure File Room (SFR) facilities located in their local office or region (if applicable)
- Oversees Project Team compliance to essential document management requirements, TMF SOPs and TMF Plans for assigned studies/programs and supervised staff
- Provides mentoring and training of new hires, project teams and external staff as needed
- Performs all departmental budgeted activities for assigned studies/programs
- Assists management with candidate review, interviews, hiring recommendations,
- Assists with on-boarding and training of department staff globally
- Serves as primary point of contact for programs and providing program level customer service and support for key Sponsor relationships
- Participates in business development presentations and system demonstrations, study KOMs and other targeted project team meetings globally as needed
- Performs eTMF System Administrator responsibilities as needed
What We Are Searching For:
- Undergraduate degree or international equivalent from an accredited institution majoring in records and information management, library science, clinical, science or health related field required - or – an equivalent level of clinical trials records management experience.
- 6+ years (of clinical trials essential document management and/or records management experience is required.
- Significant experience using computerized clinical trials records management technologies is required.
- Project, clinical and/or quality management experience preferred.
- Significant knowledge of ICH-GCP, ISO14155 and global regulations pertaining to essential document management and Trial Master File management is required.
Why Choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Project Manager, Rare Diseases
Description
Premier Research is looking for a Senior Project Manager to join ourRare Diseasesteam. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What You'll Be Doing:
- Ensuring successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
- Ensuring adherence to project budget and scope of work to realize project profitability
- Ensuring all project tasks are completed in accordance with project plans and in compliance with standard Premier Research processes, policies and procedures
- Ensuring effective communication is maintained and project status reports and monthly progress reports are provided both internally and externally
- Ensuring compliance for project-related training
- Ensuring adequate resourcing is available to meet project deliverables and milestones
What We're Searching For:
- Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
- Minimum 8 years relevant experience, preferably in a pharmaceutical company/medical device company/CRO, at least half of which has been in a matrix environment
- 5 years of experience serving as a Project Manager for complex and/or international clinical trials and/or programs
- Strong budget/finance experience on a project level
- Experience managing a study from start to completion, managing multiple phases, and managing the full lifecycle
- Rare Disease experience required
Why choose Premier?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
#LI-CI1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Vice President, Regulatory Affairs
Description
Premier Consulting, a division of Premier Research, is seeking a Senior Vice President, Regulatory Affairs. Become a part of a strategic product development and global regulatory consulting company dedicated to helping biotech and medtech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors deliver results for patients and you are essential to this process.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechTM. Join us and build your future here.
What you’ll be doing:
- Develops and implements strategic plans and objectives for organization growth in alignment with corporate strategy in delivery of high-quality regulatory services to clients and provide advice in support of clinical development planning.
- Provides leadership to teams in the preparation of regulatory strategies, review of clinical development plans, and health authority interactions for clients
- Key responsibility for building cross-functional alliances both within Premier Consulting as well with Premier Research. This includes advising internal development functions such as Clinical, Medical, Nonclinical and CMC regarding regulatory impact of development decisions
- Manages the organizational structure, staffing, resourcing, and supervision of the Global Regulatory Affairs function including line management responsibilities for multiple Regulatory Affairs sites and/or regions
- Supports Business Development efforts for opportunities including proposals, budgets, pitching calls and bid defense meetings
What we’re searching for:
- Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred
- BA/BS and 16-18 years of related experience or MA and 14-16 years of related experience or PhD and 12-14 years of related experience in the pharmaceutical, CRO or biotechnology industry, involving the conduct of clinical trials.
- Minimum of 10-15 years’ experience of managing people or processes in the regulatory affairs department.
- Experience in the preparation of regulatory submissions in the US and Europe is required
- Experience with supervisory and financial management responsibility of a regulatory affairs department or component thereof (prior experience and responsibility for financial management of a regulatory department of a CRO, pharmaceutical or consulting firm)
- Experience working in multidisciplinary project teams
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federalguidelines. All qualified applicants will receive equitable consideration without regard to race,color, religion, sexual orientation, gender identity, national origin, disability or veteran status.
#LI-EC
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistical Programmer
Description
Premier Research is looking for a Senior Biostatistical Programmer to join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech. Join us and build your future here.
What you will be doing :
For project success:
· Keeps detailed records of time spent on each project for accurate billing
· Respects and maintains the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
· Develops SAS programs to generate listings without shells
For commercial success:
· Develops and maintains overall awareness in the field of Biostatistical programming by attending training classes, professional meetings, following-up on technical developments, etc.
· Ensures that work is completed on time and at the correct level of quality
· Contributes to the tracking of project revenue and backlog
· Contributes to the tracking of hours worked on projects and forecasts hours to complete
Other
· Participates in efforts for efficiency and productivity in the department
· Performs other work-related duties as assigned
· Participate in corporate initiatives and actions that ensure the continued success of the company
· Attends project and corporate meetings as necessary
· Handles complicated or non-standard sources of data
· Other activities as designated
EDUCATION, SKILLS & COMPETENCIES:
Educational Background
· BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role
Experience
· 4-6 years of experience in SAS programming within the area of clinical trials.
· Prior experience using computerized information systems preferred.
· Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
Why Choose Premier Research?
• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
• Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Czech Republic)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Hungary)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Poland)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Romania)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Slovakia)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research
Premier Research is hiring a Remote Senior Biostatistician (Contractor Bulgaria)
Description
Premier Research is looking for a Senior Biostatisticianto join our Statistics team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- We are Built by You. Your ideas influence the way we work, and your voice matters here.
- We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What you’ll be doing:
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
- Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
- Independently prepare analysis data specifications
- Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
- Perform quality control of analysis data and TLGs
- Review and provide input in interpreting analysis result to clinical study report
What we are searching for:
- Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience
- Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Detail oriented, well organized with the ability to work on several projects simultaneously
- Excellent team player, collaborative and maintains a positive, results-orientated work environment
- Accountable, dependable and demonstrates strong commitment to the role
- Is customer service focused in approach to work, both internally and externally
Why choose Premier Research?
- Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
#LI-KT1
See more jobs at Premier Research