Job Summary
A company is looking for a Director of Biostatistics.
Key Responsibilities
- Provide strategic biostatistical leadership for pharmacokinetic (PK) and pharmacodynamic (PD) studies across all clinical development phases
- Collaborate with Clinical Pharmacology to design studies and develop statistical analysis plans (SAPs) for PK/PD endpoints
- Ensure timely delivery of high-quality statistical components for regulatory submissions and mentor junior statisticians
Required Qualifications
- Master's Degree with at least 7+ years of experience, or Ph.D. with at least 5+ years of experience
- Deep expertise in PK modeling, including non-compartmental and population PK analysis
- Experience with regulatory interactions and submissions (e.g., INDs, NDAs, BLAs)
- Experience in relevant disease areas, particularly oncology, immunology, or inflammation
- Proven ability to collaborate effectively with cross-functional teams
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