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