Director of Biostatistics

Job Summary

A company is looking for a Director, Biostatistics to provide statistical strategy for drug development programs.

Key Responsibilities

• Provide statistical strategy and oversight for multiple clinical studies or programs
• Design studies, author and review protocols and Statistical Analysis Plans (SAPs), and oversee analyses
• Support regulatory submissions and mentor junior statisticians or contractors

Qualifications

• PhD in Statistics or related field with 8+ years of clinical trial experience, or MS with 12+ years of experience
• Deep knowledge of statistical methods for clinical trials and relevant regulatory guidelines
• Proficiency in SAS or R; experience with trial design software
• Experience supporting NDAs, BLAs, MAAs, and regulatory inspections is preferred
• Ability to manage multiple priorities in a fast-paced environment