Director of Biostatistics - job 1 of 6

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