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Principal Biostatistician

Company: Cytel Software Corporation
Location: Kahului
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. We are hiring an AD/ Principal Statistician depending on years of experience and applicable knowledge for this role. This position reports to the Director of Biostatistics.Your ImpactAs an AD/Principal Statistician, 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 with Patient-Reported outcomes and supporting Health Economics and Outcomes Research.What we are looking for:

  • MS or PhD in Statistics or Biostatistics (PhD preferred).
  • 5+ years of pharma or CRO experience
  • Familiarity common PROs (and other COAs) such as QLQ-C30, PRO-CTCAE, PROMIS, etc.
  • Experience reviewing PRO/HRU/QOL data for regulatory submission.
  • Experience in analysis of PROs and support of HEOR projects
  • Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics to contribute to development of protocol and SAP.
  • Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents to contribute review of study reports and integrated analyses.
  • Experience as lead statistician is valued.
  • Good knowledge of Statistical programming in SAS. Should be able to manipulate datasets and validate statistical outputs.
  • Familiar with CDISC requirements.
  • Experience with support for EDC build.
  • Experience working on post-hoc analyses and publication support.
  • Excellent oral and written communication skills.
  • Positive attitude with willingness to share knowledge with team members.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, Maui , Principal Biostatistician, Other , Kahului, Hawaii

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