Biostatistics Director, Oncology Biosimilars- US Remote

Amgen seeks a Biostatistics Director to lead statistical strategy and oversight for oncology biosimilar clinical development programs across multiple therapeutic areas. The role involves managing statistical teams, developing regulatory strategies, and ensuring statistical excellence throughout drug development lifecycles.

Responsibilities

• Develop and maintain statistical excellence in design, analysis, and reporting across biosimilar development programs
• Hire, allocate, manage, and mentor internal statistical staff; manage budgets and resource plans
• Review clinical development plans, protocols, statistical analysis plans, regulatory documents, and submissions
• Represent statistical function in regulatory authority meetings and defend analytical approaches
• Establish statistical strategy and standards for clinical development ensuring consistency and regulatory alignment

Requirements

• Doctorate in biostatistics/statistics with 4+ years experience, OR Master's with 8+ years, OR Bachelor's with 10+ years
• Ten years post-graduate statistical experience in pharmaceutical industry or medical research with oncology expertise preferred
• Knowledge of adaptive designs, group sequential designs, Bayesian methods, and combined phase study designs
• Demonstrated leadership of regulatory submissions and cross-functional teams
• Strong written and oral communication skills for statistical strategy presentation
• Experience managing staff, CRO partners, and driving innovation in statistical methodologies
• Life cycle drug development experience from pre-clinical through post-marketing