Associate Director, CMC Statistics

The role

The Associate Director, CMC Statistics provides statistical leadership across Chemistry, Manufacturing, and Controls activities. This person will partner with various departments to develop statistical strategies for drug substance and drug product development.

What you will do

• Serve as the CMC statistical subject matter expert for biologic drug substance and drug product development, registration, commercialization, and lifecycle management.
• Develop and execute statistical strategies for specification setting.
• Lead statistical evaluation of stability data.
• Design and analyze analytical method bridging, transfer, qualification, and validation studies.
• Lead statistical planning and analysis for analytical and product comparability assessments.
• Provide statistical support for analytical control strategies, process characterization, and validation.
• Apply statistical methods such as regression, ANOVA, mixed models, and design of experiments to CMC datasets.
• Support deviations, out-of-specification and out-of-trend investigations.
• Author and review statistical analysis plans, protocols, reports, and regulatory submission sections.
• Partner with external CDMOs, CROs, and testing laboratories.

Required qualifications

• Advanced degree (PhD, ScD, or equivalent preferred; master’s degree considered) in Statistics, Biostatistics, Applied Mathematics, Data Science, Engineering, Pharmaceutical Sciences, or a related quan
• Minimum of 10 years of industry experience applying statistics to biologics CMC activities in a biopharmaceutical or biotechnology setting.
• Direct, substantial experience with specification setting, stability trending and shelf-life assessment, analytical method bridging, and comparability assessment is required.
• Demonstrated experience supporting biologic drug substance and drug product programs and working with analytical, manufacturing, quality, and regulatory data.
• Strong command of statistical methods relevant to CMC, including regression, ANOVA, mixed models, equivalence and non-inferiority approaches, tolerance intervals, control charts, capability analysis,
• Experience applying statistical principles to analytical method qualification, validation, transfer, lifecycle monitoring, and investigations.
• Working knowledge of applicable ICH guidance, FDA and EMA expectations, cGMP requirements, and data-integrity standards for biologics development and commercialization.
• Proficiency with one or more statistical software platforms such as JMP, SAS, R, Python, or Minitab.
• Experience authoring or reviewing technical protocols, statistical analysis plans, reports, regulatory submission content, and health authority responses.
• Excellent written and verbal communication skills.

Nice to have

• Experience with monoclonal antibodies, bispecific antibodies, or other complex biologics.
• Experience supporting late-stage development, BLA/MAA submissions, commercial readiness, process validation, PPQ, post-approval changes, and product lifecycle management.
• Experience operating in an outsourced or virtual development model with CDMOs, CROs, and external testing laboratories.
• Experience establishing CMC statistical standards, procedures, templates, analysis plans, or governance frameworks.
• Familiarity with data visualization and reporting tools such as Spotfire, Tableau, or comparable platforms.

Benefits

• Bonus
• Stock
• Benefits

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.