Director, Biostatistics
Core
Director of Biostatistics leading clinical trial design, statistical support for drug development, and regulatory submissions within a therapeutic area.
Role type
Senior IC Director of Biostatistics (Clinical Development)
Builds
Clinical Development Plans, regulatory submissions, and statistical strategies for new medicines
Domain
Pharmaceutical industry, Oncology/Hematology/Cardiovascular/Neuroscience
Required skills
Advanced statistical analysis, SAS/R/Python, clinical trial design, regulatory agency interaction, team management, budget management, strategic planning
Preferred skills
PhD in statistics/biostatistics, 9+ years experience, 3+ years management experience, workforce planning expertise
Technologies
SAS, R, Python
Responsibilities
Drive innovative study designs supporting regulatory approval; lead statistical support for compound development; manage statisticians and ensure high-quality deliverables; present statistical solutions to governance and regulatory bodies; manage functional/project budgets; coach and develop biostatistical team members.
Seniority
Director, hands-on IC with management responsibilities