Associate Director, CMC Statistics

The Associate Director, CMC Statistics provides statistical leadership for Chemistry, Manufacturing, and Controls (CMC) activities, partnering with cross-functional teams to develop regulatory-defensible statistical strategies for drug substance and product development. This role involves supporting specification setting, stability trending, analytical method validation, and comparability assessments to ensure global regulatory compliance and commercial readiness. The position requires translating complex CMC datasets into clear conclusions and recommendations for senior leadership and health authorities.