Principal Biostatistician
Location: Remote
Compensation: To Be Discussed
Staff Reviewed: Fri, Nov 22, 2024
This job expires in: 16 days
Job Summary
A company is looking for a Principal Biostatistician to lead biostatistics planning activities in clinical development programs.
Key Responsibilities
- Devise and lead statistical strategies for clinical development, including pivotal Phase 2/3 studies and regulatory submissions
- Ensure accuracy and statistical integrity of analysis and reporting deliverables
- Manage biostatistics vendors and provide oversight on in-house and external statistical service activities
Required Qualifications
- Ph.D. in Statistics or Biostatistics with 5+ years of pharmaceutical experience, or a master's degree with 10+ years of relevant experience
- Expertise in statistical methodology applicable to pharmaceuticals/biotechnology
- Experience in late-stage clinical trials, particularly Phase 3 planning and reporting
- Strong programming skills in R and familiarity with CDISC, SDTM, and ADaM data models
- Ability to work cross-functionally with basic science research and clinical colleagues
COMPLETE JOB DESCRIPTION
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