Principal Biostatistician

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 a remote Senior/Principal Biostatistician to lead and support clinical trials for a major pharma company in the therapeutic area of Rare Diseases.  This position reports to the Director, Biostatistics in the FSP Services business unit in Cytel.  The level of the position will be determined by the candidate’s experience level.

Your Impact

As a Senior/Principal Biostatistician, you will provide statistics input into the end to end process of clinical trials, including protocol development, review and development of SAP, associated TFL shells and specifications to programmers, review of ADaM and SDTM datasets, preparation, review, and interpretation of statistical analyses, and preparation of submission data packages for regulatory agencies.

What we are looking for:

• Master’s or PhD in Biostatistics or related field
• 5 years’ experience in clinical trials, with experience serving at a clinical study lead
• Good knowledge of SAS programming (e.g., must be able to verify statistical output)
• Good knowledge of research methodology and statistical approaches to analyzing data
• Prior experience working on regulatory agency’s requests, such as FDA IR, EMA RTQ will be a plus
• Prior experience working with outcome research, marketing or payer activity groups will be a plus
• Familiarity with Pharmaceutical industry and regulatory requirements for the drug development
• Effective communicator:
  • able to explain methodology and consequences of decisions in lay terms
  • able to summarize questions from statistics team over to programmers
• 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
• Excellent organizational and time management skills
• Experience in Rare Diseases is not required

Relevant statistical techniques needed:

• Proficiency in SAS statistical procedures for conducting efficacy and safety analyses (e.g., time to event analyses, familiarity with regression models are a plus)

• Experience
• Experience with relevant ICH guidelines
• Experience with CDISC standards