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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 Vice President, Marketing

Description

Position at Premier Research

Premier Research is looking for aVice President, Marketingto join our Marketing 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 BiotechTM.Join us and build your future here. 

WhatYou’ll BDoing:     
  • Translates business priorities into marketing strategies and tactics in conjunction with other teams to achieve broad financial and strategic goals 
  • Maximizes return from current platform product capabilities and develop new product requirements to further improve consumer experience and business growth 
  • Builds amazing, diverse teams and a winning culture that encourages innovation and mentorship. Establish motivating stretch objectives for team members that align with company objectives. Encourage coaching and mentoring, focus on the development needs of employees and ensure collaboration and teamwork 
  • Strategically plans a wide variety of vehicles that foster favorable industry and market visibility including, but not limited to: corporate and therapeutic tradeshow and conference attendance, advertising, public relations, direct mail campaigns, website and internet presence and use
  • Provides support and market analysis for business development and operations
  • Works with Executive and Senior Management on development of all Marketing strategies and planning for Premier Research Group

    What WAre Searching For:        

    • Minimum Bachelor's degree in business or marketing (MBA preferred). Marketing and/or business degree from an accredited college
    • Minimum 15 years of direct experience in marketing with Senior Management experience. CRO experience is highly preferred.
    • Ability to manage remote workforce
    • Excellent persuasive/selling skills
    • Excellent communication skills (interpersonal, written, verbal)
    • Demonstrated strong, formal presentation skills
    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 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. 

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    Premier Research is hiring a Remote Director, Business Development (Boston)

    Description

    Position at Premier Research

    Premier Research is looking for aDirector of Business Development to join our Business Development 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 BiotechTM. Join us and build your future here. 
       
    What You'll Be Doing: 
    • 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
     
    What we are searching for:   
    • Bachelor's degree in scientific discipline (MBA preferred) 
    • Minimum of three years direct experience in consultative sales (preferably in CRO or related service industry) 
    • Familiarity with pharmaceutical drug development and/or medical device development processes 
    • Experienced negotiation skills
    • Formal presentation skills
    • This role requires travel based on business needs  
     
    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  

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    Premier Research is hiring a Remote Principal Biostatistician

    Description

    Position at Premier Research

    Premier Research is looking for a Principal Biostatistician to join our Biostatistics 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 medical innovation that patients are desperate for.
    Together, we are Built for BiotechSM. Join us and build your future here.     
    The Principal Biostatistician generates derived datasets, tables, listings, and figures (TLFs) of clinical trial data, performs quality control of TLFs and derived data sets created by other Biostatisticians, and may be asked to assist in the preparation of statistical plans. The Principal Biostatistician successfully supports Biostatistics leads and senior reviewers in the execution of deliverables by managing the timelines and budget of assigned tasks. This individual supports Business Development by assisting with Biostatistics costs for proposals and attending bid defense and capabilities meetings when required. Additionally, the Principal Biostatistician prepares specifications for analysis data sets and independently drafts statistical analysis plans. This individual also acts as Lead Biostatistician on assigned projects, interacts with the study team and the Sponsor, and is responsible for tracking project revenue, backlog, and hours worked on projects, and will forecast the necessary hours to complete a project. In addition, he/she also supervises SAS programming and program validation for projects.
     
    What you'll be doing:
    • Acts as project manager for biostatistics stand-alone work
    • Provides consultancy to sponsors on statistical issues.
    • Independently develops SAS programs to generate randomization codes.
    • Provides statistical input to Clinical Trial Protocols
    • Develop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
    • Presents biostatistical capabilities in bid defense meetings.
    What we are searching for:
    • Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field. Equivalent combination of education, training and experience will be considered.
    • 12-15 years’ experience in clinical trials design and analysis
    • Demonstrated expert working knowledge of basic clinical trial design and analysis principles.
    • Expert working knowledge of CDISC standards and application of these standards to projects.
    • Expert working knowledge and understanding of advanced statistical concepts
    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 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.
    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.
     

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    Premier Research is hiring a Remote Senior Biostatistician (contractor)

    Description

    Position at Premier Research

    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     

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    29d

    TMF Lead I

    Premier ResearchRemote, Romania

    Premier Research is hiring a Remote TMF Lead I

    Description

    Position at Premier Research

    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 
     

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    Premier Research is hiring a Remote TMF Lead I - Poland

    Description

    Position at Premier Research

    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 
     

    See more jobs at Premier Research

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    Premier Research is hiring a Remote TMF Lead I - Bulgaria

    Description

    Position at Premier Research

    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 
     

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    Premier Research is hiring a Remote Senior Vice President, Regulatory Affairs

    Description

    Position at Premier Consulting

    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

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    Premier Research is hiring a Remote Senior Biostatistical Programmer

    Description

    Position at Premier Research

    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

    Apply for this job

    Premier Research is hiring a Remote Senior Biostatistician (Contractor Czech Republic)

    Description

    Position at Premier Research

    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

    Apply for this job

    Premier Research is hiring a Remote Senior Biostatistician (Contractor Hungary)

    Description

    Position at Premier Research

    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

    Apply for this job

    Premier Research is hiring a Remote Senior Biostatistician (Contractor Poland)

    Description

    Position at Premier Research

    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

    Apply for this job

    Premier Research is hiring a Remote Senior Biostatistician (Contractor Romania)

    Description

    Position at Premier Research

    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

    Apply for this job

    Premier Research is hiring a Remote Senior Biostatistician (Contractor Slovakia)

    Description

    Position at Premier Research

    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

    Apply for this job

    Premier Research is hiring a Remote Senior Biostatistician (Contractor Bulgaria)

    Description

    Position at Premier Research

    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

    Apply for this job

    Premier Research is hiring a Remote Director, Biostatistical Programming

    Description

    Position at Premier Research

    Premier  Research is looking for a Director, Biostatistical Programming to join our Biostatistics 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 medical innovation that patients are desperate for.
    Together, we are Built for BiotechSM. Join us and build your future here.     
    The Director, Biostatistical Programming serves as core team member and leader for larger projects. This position is responsible for Biostatistical Programming operations, directing project assignments, and the overall activities of project team personnel.  The Director also reviews departmental deliverables for accuracy, completeness, and compliance with project specifications to ensure quality deliverables to Sponsors. The Director is responsible for both management and technical aspects of development projects.  As a technical expert, this individual provides strategic guidance to development projects. When functioning in a supervisory role, the Director provides coaching guidance to more junior staff and line management to the team, while overseeing the technical evolution of the departmental work product.   
         
    What you will be doing:     
    • Supervises, mentors, and motivates reporting associates in tasks and activities to develop and maintain the team structure.
    • Provides support for the maintenance and management of the biostatistics macro library.
    • Prepares specifications for CDISC and other analysis data sets.
    • Performs QC (source code review, double-programming and log review) of SAS programs.
    • Participates in and contributes to the training and development of new Biostatistical Programmers
    • Lead efforts in the development, maintenance and adherence to departmental SOPs and guidelines
    • Keeps up on CDISC and other industry standards and ensures dept is kept up to date.
    • Integrates operational practices within the department across all offices/regions.
    • Develops SAS programs to generate tables and listings without shells.
    • Develops SAS programs to generate listings, tables and graphs as outlined by TLF shells.
    • Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team.
       
    What are we looking for:     
    • BS or equivalent from accredited college or university, in statistics, IT, mathematics or equivalent experience with programming in a scientific field. Equivalent combination of education, training and experience will be considered.
    • 9+ years’ experience in SAS programming within the area of clinical trials.
    • 7+ years’ experience as supervisor/manager.
    • Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques..
    · 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

    Apply for this job

    Premier Research is hiring a Remote Principal Biostatistical Programmer

    Description

    Position at Premier Research

    Premier Research is looking for Principal Biostatistical Programmerto join our Biostatistics 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 medical innovation that patients are desperate for.
    Together, we are Built for BiotechSM. Join us and build your future here.   
       
    The Principal Biostatistical Programmer is responsible for the production of project-related datasets, tables, listings, and figures (TLFs) required for delivery to Premier Research Sponsors.  This individual also performs Biostatistical programming, quality control, and validation to support global Biostatistics projects.  This work is completed through the development and validation of SAS software programs, macros, and utility tools.  The Principal Biostatistical Programmer also prepares specifications for data set analysis.     
       
    The Principal Biostatistical Programmer acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team.  Additionally, he/she contributes to the tracking of project revenue, backlog, and hours worked on projects, along with forecasting the hours required to complete a project.    
       
    What you will be doing:

    The Principal Biostatistical Programmer: 
      
     
    • Develops SAS programs to generate listings without shells.
    • 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.
    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 
    What are we looking for:   

    1. 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.   
       
    2. Experience   
    • 6-8 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.
    • Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques
    • Demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms.
    • Evidence of advanced SAS programming skills.
    • Demonstrated working knowledge of data processing, database design and organization in clinical data environment.
    • Demonstrated working knowledge of basic clinical trial design and analysis principles.
    • Working knowledge of CDISC standards and application of these standards to projects.
    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.   

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