Senior Biostatistician

Company: Cytel Inc
Location: South Bend
Posted on: July 18, 2021

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 a remote Senior Biostatistician to lead and/or support Gastrointestinal studies/projects, regulatory queries, and publications.  This position reports to the Sr. Director, Biostatistics.

This is a Senior Statistician or Principal Statistician role depending on years of experience and applicable knowledge.

Your Impact

As a seasoned 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 in late-phase trials and regulatory submissions for Gastrointestinal studies.

What we are looking for:

• Master’s or PhD in Biostatistics, or related discipline
• 5-10 years’ experience on clinical trials
• At least 3 years of recent late-phase trials (II & III) for drug development, including submissions experience including ISS/ISE
• Study Lead experience working with cross-functional teams. Experience leading global projects, a plus
• When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes
• Strong knowledge of full clinical trial process with experience writing SAPs, reviewing and verifying key statistical outputs
• 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

What’s 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 Cytel’s history with high growth and opportunities to progress your career
• Work with and leverage the best and brightest minds in the industry

Keywords: Cytel Inc, South Bend , Senior Biostatistician, Other , South Bend, Indiana