Associate Director, CMC Statistician

Job Summary

To support the Global Analytical organization, the remote Associate Director, CMC Statistician will provide statistical leadership for specification setting and Justification of Specifications across late-stage development, collaborating with various teams to ensure regulatory-ready approaches in vaccine development.

Key responsibilities

• Serve as the CMC statistical lead for the Vaccine Specification Working Group, supporting specification-setting strategy for drug substances and products
• Develop and execute statistical analyses, including regression, ANOVA, and control charts, to inform specification and lifecycle management
• Author and review statistical sections of technical reports and regulatory submissions, translating complex statistical concepts for cross-functional teams

Required qualifications

• MS or PhD in Statistics, Biostatistics, Applied Statistics, Mathematics, Data Science, or related quantitative discipline with 10+ years of experience in the pharmaceutical or biotechnology industry
• Significant hands-on experience in CMC statistics, including specification setting and analytical method evaluation
• Demonstrated experience supporting BLA, MAA, IND, or major health authority submissions
• Strong expertise in statistical methods relevant to CMC and analytical development
• Proficiency with statistical software such as R, SAS, JMP, or Python