Director of Biostatistics

Job Summary

A company is looking for a Director of Biostatistics to provide strategic and hands-on leadership for statistical activities across clinical development programs.

Key Responsibilities

• Lead statistical activities for clinical programs, providing strategic input on study design and analysis
• Oversee the design and execution of clinical study protocols and ensure alignment with regulatory guidance
• Lead statistical contributions to regulatory submissions and represent Biostatistics in interactions with health authorities

Required Qualifications

• Minimum of a Master's degree in Statistics or Biostatistics
• At least 7 years of experience in biostatistics within pharmaceutical or biotech industries
• Experience leading statistical activities in Phase I-III clinical trials
• Knowledge of regulatory submissions and health authority interactions
• Ability to operate effectively in both structured and agile development environments