Principal Biostatistician

Company: Cytel Software Corporation
Location: Lynn
Posted on: June 18, 2022

Job Description:

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward. At Cytel, we work to create successful careers with significant professional growth for our employees. Our Functional Service Provider (FSP) division is looking for a talented Principal Biostatistician to lead and/or support statistical activities on Gastrointestinal studies/projects, regulatory queries, and publications. In FSP, you will be fully integrated into a pharmaceutical companys team and work according to their SOPs directly in their systems and SAS server environment. This position would report to a Director of Biostatistics and may be a Principal or Senior Statistician level depending on years of experience and applicable knowledge.Your ImpactAs an Associate Director, Biostatistics, you will be dedicated to one of our major Pharma clients, working as an extension of their staff to lead and support clinical trials for drug development, with the opportunity to leverage your experience in late-phase trials and regulatory submissions for Gastrointestinal studies.What we are looking for:

• Masters or PhD in Biostatistics, or related discipline
• 10+ years experience on clinical trials
• At least 3 years of recent late-phase trials (II & III) for drug development, including experience in drafting SAPs/calculating sample size/reviewing TLFs
• Have strong SAS and/or R programming skills with some experience in running simulations using either SAS or R
• When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables, and processes
• Good experience verifying key statistical outputs
• Experience in Gastro-Intestinal studies or submission experience is a plus
• Strong knowledge of pharmaceutical industry and regulatory environment
• Effective communicator: able to explain methodology and consequences of decisions in lay terms
• Team player; willingness to go the extra distance to get results, meet deadlines, etc.
• Ability to be flexible when priorities change and deal with ambiguity Whats in it for you:
  • You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
  • You will work with a dynamic, innovative statistics team
  • You will be part of an exciting new chapter in Cytels history with high growth and opportunities to progress your career
  • Work with and leverage the best and brightest minds in the industryRequired
    Preferred

    Job Industries

    • Customer Service

Keywords: Cytel Software Corporation, Lynn , Principal Biostatistician, Other , Lynn, Massachusetts