Director / Senior Director of Biostatistics

15 Jun 2021
15 Jul 2021
Robert Angrave
Full Time
Contract Type
Experience Level
Senior Management
CK Group are working with an innovative and fast growing biotech company to recruit a Director of Biostatistics to join them on a perm basis, in the Massachusetts area.

Our client is an immunotherapy company located in Waltham MA, established to pioneer the next generation of immunotherapies. They are committed to enabling the world with these transformative reagents in order to accelerate biological discovery and the development of new therapeutics.

This role will provide candidates with expertise in the design of clinical trials, statistical analyses of clinical data for organizational decision-making, regulatory submissions, process optimization, and resource planning. As Director or Senior Director will you will lead, manage, and coordinate global biostatistics activities for the company’s portfolio in collaboration with the Research, Clinical Development, and external vendors.

Job Responsibility:
  • Serve as the expertise from beginning of the study design through to final data reporting and regulatory submissions
  • Strategic planning, including development and implementation of clinical development plans and statistical analysis plans
  • Application of innovative statistical methods including adaptive study designs and analysis of clinical study data
  • Active participation in randomization development and validation process
  • Preparation of statistical section of clinical study protocols and reports
  • Review of protocols, case report forms, statistical analysis plans and clinical study reports
  • Ph.D. in Statistics/ Biostatistics with 7+ years of experience in the pharmaceutical industry
  • Experience in designing oncology Phase I/II/III clinical trials.
  • Experience in designing and implementing several dynamic randomization plans
  • Experience with application of a variety of statistical methods and ability to work on complex statistical problems
  • Experience in forming DSMB, organizing DSMB meetings, providing data ad communicating with DSMB members
  • Solid knowledge of SAS and familiarity with other statistical software packages
  • Have thorough understanding of regulatory guidance and statistical methodology as applied to pharmaceutical development
  • With knowledge of IND, NDA/BLA data submission requirements
Please quote 50895 in all communications.
It is essential that you have the rights to work in the USA.