Description

• 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. 

Description

• 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.    

As the Site Start Up Associate, you'll have the opportunity to showcase your expertise to perform all tasks with the start-up of a clinical trial in accordance with all regulations, standards, and study-specific requirements. You’ll be able to liaise and represent SSU with several members of the Study team as it pertains to Start-Up.

What you'll be doing:

• Prepare and submit Local IRB Applications, RA Applications, and other local regulatory authorities or hospital approval submissions; prepare ongoing submissions, amendments, and periodic notifications required by central and local EC and RA; submit end of study notifications to Regulatory Authorities, Ethics Committees/Review Boards and other local authorities.
• Perform essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with local regulatory requirements and ICH/GCP guidelines.
• Investigator Contract and budget negotiator - produce site contracts and submit proposed contract and budget for site; negotiate budget and contract with site and via Contracts Lead with Sponsor.
• Provide all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up; ensure accuracy and completeness of trial master file documents submitted during start-up and perform QC review before transfer to Maintenance for filing in TMF.
• Liaise with internal team members to review areas that impact study start-up and share start-up information with the project team.
• Provide country-level intelligence on site start-up and ensure that regulatory intelligence is maintained on the central repository; maintain a country folder with country Ethics Committees/Review Board and local authority addresses and requirements.
• Support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.
• Review and advise on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements; provide training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.

• Undergraduate degree in a clinical, science, or health related field along with 2 years’ experience in the submission of clinical trial applications.
• Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials. Knowledge of site and institution specific contract requirements; proven proficiency in the development and review of Informed Consent Form templates
• Knowledge of web-based communication tools for conferences and any other IT systems required for the job
• Strong verbal and written communication and negotiation skills; fluent verbal and written English required for clinical trial submissions
• Excellent organizational and time-management skills, able to prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment

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-JD1

Description

Description

• 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 medical innovation that patients are desperate for.  

• Identifies, qualifies and secures client meetings for potential business opportunities related to projects requiring clinical research and consulting services both for target and exploratory accounts
• Obtains Requests for Proposals (RFPs) and assists in proposal development and facilitates presentations at client site as required
• Secures contract awards based on above efforts and sales targets and assists with maintaining client satisfaction by monitoring and assisting with change orders related to current contracts
• Provides project team support as appropriate

• Bachelor's degree in scientific discipline (MBA preferred)
• Minimum of five years direct experience in consultative sales (preferably in CRO or related service industry), management experience helpful
• Familiarity with pharmaceutical drug development and/or medical device development processes
• Located in Mid-Atlantic region
• Ability to perform overnight business travel, up to 40%

• 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. 

Description

• 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 medical innovation that patients are desperate for.   

• Serves as primary Clinical Data Sciences contact in assigned studies and ensures that data cleaning is performed in a consistent way between team members.
• Coordinates all tasks within the data science process between different team members from
• database development to database lock.
• Prepares data science plans, data entry guidelines, data science reports and other documents.
• required for preparing and completing databases.
• Supports database development activities and coordinates database amendments in collaboration with the database development team.
• Provides leadership and advice to Data Coordinators (DCs) and trainees on Clinical Data Science procedures, SOPs, ICH-GCP
• Provides and/or co-ordinates training and mentoring of DCs and trainees.
• Helps to assess DC performance and execute annual appraisals, monitors career development, and performs end-of-probationary-period reviews.  

• 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. 

Description

• 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 medical innovation that patients are desperate for.  

• 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 

• Demonstrated results as a Senior Records Specialist or equivalent in a clinical trials essential document management and/or records management setting is preferred. 
• 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. 
• Global clinical trials experience is required. 
• Knowledge of global/national health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the clinical trial essential document management and records management activities will be performed is required. 

• 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. 

Description

• Provides oversight and trial management of the planning, execution, and completion of clinical trials in accordance with all applicable regulations and guidance including ICH/GCP
•  Ensures successful management and coordination of all members of the trial operations team, to support milestone achievement and overall project delivery
• Provides clinical operations oversight in the evaluation and selection of investigative sites and vendors (e.g. – central labs, IVRS, etc.), and drives the successful activation of trial sites according to time, quality/scope, and budget parameters
• Oversees study finance management that may include budget review, change orders, reconciling of forecast/actual variance, allocation of FTE, productivity oversight, etc.
• Facilitates the development and review of project documentation, such as Case Report Forms, Source Documents, templates and study plans. May contribute to the review of protocol/study design, informed consent forms, and be a reference point for CRAs and investigative sites
• Manages recruiting efforts and activities to meet study enrollment goals, overseeingboth patient recruitment and retention together with other functional leads in order to meet project milestones  

• Bachelor’s degree, or its international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field; or equivalent combination of education, training, and experience
• 7-10 years of clinical research experience, including 3 years of clinical/study oversight experience and 5 years of clinical monitoring. Global study management, study finance, early phase, and FSP experience highly preferred.
• Managed Access Program experience highly preferred
• Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
• Demonstrates excellent English verbal and written communication skills
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities

Description

• Works with cross-functional study team members in a programming capacity to create reporting solutions that support the quality and timely delivery of data management reports and visualizations required per standard and study specific data review plans

• Creates, enhances, and decommissions data management reports in accordance with applicable standard operating procedures

• Ensures timelines and milestones are met in collaboration with cross functional teams

• Creates any needed documentation for reports and ensures proper filing

• Works across the portfolio to increase automated reporting (e.g. - JReview, Spotfire) and review in order to streamline effort on data intensive studies

• Enhances available reporting tools or creates new ones to support the review of clinical trial data and trial status information for cross-functional use

• Provides input on data management reporting standards as required

• Bachelor’s degree, or international equivalent from an accredited institution, preferably in a programming, technical, clinical, or health-related field, or equivalent combination of education, training and experience

• 3 to 5 years of practical experience using commercial clinical data management systems (e.g. – Oracle RDC / Inform, Medidata Rave, Datalabs, etc.) or data visualization reporting tools (e.g. Spotfire, jReview). Alternatively, must have proven experience in all primary job functions

• Practical experience with SQL or similar programming language required

• Demonstrates excellent English verbal and written communication skills

• Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (e.g. - Outlook, Work, Excel, etc.)

Description

• Works with cross-functional study team members in a programming capacity to create reporting solutions that support the quality and timely delivery of data management reports and visualizations required per standard and study specific data review plans

• Creates, enhances, and decommissions data management reports in accordance with applicable standard operating procedures

• Ensures timelines and milestones are met in collaboration with cross functional teams

• Creates any needed documentation for reports and ensures proper filing

• Works across the portfolio to increase automated reporting (e.g. - JReview, Spotfire) and review in order to streamline effort on data intensive studies

• Enhances available reporting tools or creates new ones to support the review of clinical trial data and trial status information for cross-functional use

• Provides input on data management reporting standards as required

• Bachelor’s degree, or international equivalent from an accredited institution, preferably in a programming, technical, clinical, or health-related field, or equivalent combination of education, training and experience

• 3 to 5 years of practical experience using commercial clinical data management systems (e.g. – Oracle RDC / Inform, Medidata Rave, Datalabs, etc.) or data visualization reporting tools (e.g. Spotfire, jReview). Alternatively, must have proven experience in all primary job functions

• Practical experience with SQL or similar programming language required

• Demonstrates excellent English verbal and written communication skills

• Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (e.g. - Outlook, Work, Excel, etc.)

Description

• 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. 

• Identifies and qualifies business opportunities related to potential projects requiring clinical research services both for target and exploratory accounts 
• Assists in proposal development and facilitates presentations at client site 
• Secures contract awards based upon predetermined financial targets by cultivating and maintaining client relationships (additional responsibility for global accounts) 
• Obtains requests for proposals 
• Assists with maintaining client satisfaction
• Monitors and assists with change orders related to current contracts

• Bachelor's degree in scientific discipline (MBA preferred) 
• Minimum of three years direct experience in consultative sales, preferably in the CRO or Biotech industry
• Familiarity with pharmaceutical drug development and/or medical device development processes 
• Excellent communication, formal presentation and persuasive negotiation skills
• This role requires travel based on business needs
• Must be located in San Diegoor San Francisco

• 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. 

Description

• 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 medical innovation that patients are desperate for.  

• Prospecting and pursuing new opportunities for theFunctional Service Provider (FSP)segments of the business 
• Securing contract awards based upon predetermined financial targets by cultivating and maintaining client relationships
• Identifying and qualifying business opportunities related to potential projects requiring clinical research services both for target and exploratory accounts
• Obtaining requests for proposals and securing client meetings
• Assisting in proposal development and facilitates presentations at client site
• Monitoring and assisting with change orders related to current contracts

• Bachelor's degree in scientific discipline (MBA preferred)
• Minimum of three years direct experience in consultative sales at a CRO with Functional Service Provider (FSP) sales experience in the United States
• Familiarity with pharmaceutical drug development and/or medical device development processes
• Excellent communication, formal presentation and persuasive negotiation skills
• This role requires travel based on business needs

• 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. 

Description

• 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. 

• Identifies and qualifies business opportunities related to potential projects requiring clinical research services both for target and exploratory accounts 
• Assists in proposal development and facilitates presentations at client site 
• Secures contract awards based upon predetermined financial targets by cultivating and maintaining client relationships (additional responsibility for global accounts) 
• Obtains requests for proposals 
• Assists with maintaining client satisfaction
• Monitors and assists with change orders related to current contracts

• Bachelor's degree in scientific discipline (MBA preferred) 
• Minimum of three years direct experience in consultative sales within the Boston area, preferably in the CRO or Biotech industry
• Familiarity with pharmaceutical drug development and/or medical device development processes 
• Excellent communication, formal presentation and persuasive negotiation skills
• This role requires travel based on business needs
• Must be located in the Boston, MA area

• 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. 

Description

• 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.

• 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

• 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

• 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.

Description

Description

• 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.

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

• 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.

Description

• 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.

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

• 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.

Description

• 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.

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

• 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.

Description

• 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.

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

• 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.

Description

• 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.

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

• 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.

Description

• 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.

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

• 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.