Associate Director, CMC Statistician

Role: Associate Director, CMC Statistician, leading statistical strategies for vaccine specification setting and justification across late-stage development, PPQ, BLA readiness, and commercial lifecycle management at Vaxcyte. Responsibilities include developing statistical approaches for drug substance, drug product, and raw materials, supporting regulatory submissions, authoring technical reports, and collaborating cross-functionally with Process Development, MSAT, Stability, QA, Regulatory Affairs, and Manufacturing. The role emphasizes analytical method evaluation, stability analysis, process validation, and lifecycle management, translating complex statistics into clear recommendations for regulatory and internal audiences. Requirements: MS or PhD in Statistics, Biostatistics, Applied Mathematics, or Data Science with 10+ years in biotech/pharma, particularly supporting BLA/MAA/IND submissions. Expertise in CMC statistics, analytical method evaluation, stability, process validation, and familiarity with vaccines, biologics, or complex modalities is preferred. Strong proficiency in R, SAS, JMP, or Python and comprehensive knowledge of global regulatory standards (FDA, EMA, ICH) are essential. The position reports to the Senior Director, Global Analytical Lead, and is based remotely from San Carlos, CA, with a competitive salary range of $170,000-$198,000 plus benefits and an equity component.