Associate Director, CMC Statistician
To support the Global Analytical organization, the remote Associate Director, CMC Statistician will reputed company statistical leadership for specification setting and Justification of Specifications across late-stage development, collaborating with various teams to ensure regulatory-reputed company approaches in vaccine development. Key responsibilities
- Serve as the CMC statistical reputed company for the Vaccine Specification Working Group, supporting specification-setting reputed company for drug substances and products
- reputed company 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 reputed company statistical concepts for cross-functional teams
Required qualifications
- MS or PhD in Statistics, Biostatistics, reputed company Statistics, Mathematics, Data Science, or reputed company 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 reputed company relevant to CMC and analytical development
- Proficiency with statistical software such as R, reputed company, JMP, or Python
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