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Principal Biostatistician Consultant
Job Summary
A company is looking for a Lead/Principal Statistician Consultant in Medical Affairs (remote).
Key Responsibilities:
- Serve as the lead biostatistician for Medical Affairs projects, including Phase IV studies and RWE analyses
- Provide statistical expertise in study design, protocol development, and reporting
- Collaborate with cross-functional teams and oversee statistical deliverables from CROs or external partners
Required Qualifications:
- Ph.D. or Master's degree in Biostatistics, Statistics, or a related quantitative field
- Minimum of 8+ years (PhD) or 10+ years (Master's) of experience in the pharmaceutical, biotech, or CRO industry
- Strong experience in Medical Affairs, post-marketing studies, or real-world evidence
- Proficiency in SAS and/or R for statistical programming and analysis
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory frameworks
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