Principal Biostatistician

Date: Jan 11, 2023

Location: US

Company: Cytel Software Corporation

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 Principal Biostatistician to lead and/or support clinical trials for a major pharma company in the therapeutic area of Oncology.  This position reports to the Director, Biostatistics in Cytel.

 

Your Impact

 

As a Principal Biostatistician will provide statistics input into the end to end process of clinical trials, including protocol development, development & review of SAPs, associated TFL shells and specifications to programmers, review of ADaM and SDTM datasets, preparation, review, and interpretation of statistical analyses.

 

What we are looking for:

  • Master’s or PhD in Biostatistics or related field
  • 5+ years’ experience in clinical trials, with some 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 (e.g., time to event analyses, survival analysis)
  • Working experience in Oncology clinical trials with ADaM knowledge, SAP development, CSR writing, ad-hoc requests
  • Knowledge regarding regulatory submissions is 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
  • Team player with positive attitude and good communication skills
  • Ability to be flexible when priorities change and deal with ambiguity
  • Excellent organizational and time management skills
  •  

Relevant statistical techniques needed:

  • Experience with relevant ICH guidelines
  • Experience with CDISC standards

 

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 be part of an exciting new chapter in Cytel’s history with high growth and opportunities to learn and grow your career.
  • Work with and leverage the best and brightest minds in the industry.