Senior Director of Biostatistics
Location: Remote
Compensation: Salary
Staff Reviewed: Wed, Nov 20, 2024
This job expires in: 18 days
Job Summary
A company is looking for a Senior Director of Biostatistics to lead biostatistics activities for clinical development programs.
Key Responsibilities
- Lead statistical strategy and technical activities for clinical programs, including study design and regulatory submissions
- Collaborate with cross-functional teams to develop regulatory documents and oversee CRO/vendor activities for compliance
- Drive quantitative evaluations of study design options and support the development of tools for clinical trial design and simulation
Required Qualifications
- M.S. or Ph.D. in Statistics or Biostatistics
- At least 8 years of relevant experience for M.S. holders or 6 years for Ph.D. holders in the pharmaceutical or biotechnology industry
- Deep understanding of statistical designs and methods for clinical development programs
- Experience with regulatory requirements and prior interaction with health authority agencies such as FDA and EMA
- Proficient R programming skills; expert skills preferred
COMPLETE JOB DESCRIPTION
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