Associate Director, CMC Statistics

Summit Therapeutics•Princeton, NJ

3d•Onsite

About The Position

The Associate Director, CMC Statistics, provides hands-on statistical leadership across Chemistry, Manufacturing, and Controls (CMC) activities for biologic drug substance and drug product development. The role partners with Analytical Sciences, MSAT, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external CDMOs and CROs to develop scientifically sound, phase-appropriate, and regulatory-defensible statistical strategies. The position supports specification setting, stability and shelf-life assessment, analytical method bridging and transfer, comparability assessments, method validation, process and product monitoring, investigations, and lifecycle management. It translates complex CMC datasets into conclusions, risk assessments, and recommendations that support regulatory submissions, commercial readiness, and ongoing product control. The position is based onsite at Summit’s Princeton, New Jersey office, with in-office presence required four days per week. Periodic travel may be required for external partner oversight, technical meetings, audits, inspections, regulatory interactions, and cross-functional workshops. The role reports to the Executive Director, Analytical Sciences. Compensation is listed at $180,000–$200,000 USD; actual compensation varies by candidate and location, and the total package may include bonus, stock, benefits, or other variable compensation.

Requirements

Advanced degree in Statistics, Biostatistics, Applied Mathematics, Data Science, Engineering, Pharmaceutical Sciences, or a related quantitative discipline; a PhD, ScD, or equivalent is preferred, and a master’s degree is considered.
At least 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.
Experience supporting biologic drug substance and drug product programs and working with analytical, manufacturing, quality, and regulatory data.
Strong command of CMC-relevant statistical methods, including regression, ANOVA, mixed models, equivalence and non-inferiority approaches, tolerance intervals, control charts, capability analysis, multivariate methods, and design of experiments.
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, and ability to produce reproducible, traceable analyses and effective data visualizations.
Experience authoring or reviewing technical protocols, statistical analysis plans, reports, regulatory submission content, and health authority responses.
Excellent written and verbal communication skills, including the ability to explain statistical concepts and business implications to non-statistical audiences.
Ability to work independently, exercise sound scientific judgment, influence cross-functional teams, and manage multiple priorities with high attention to quality and detail.

Nice To Haves

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.

Responsibilities

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, including release and stability acceptance criteria, control limits, tolerance intervals, and decision rules.
Lead statistical evaluation of stability data, including trend analysis, shelf-life and retest-period modeling, protocol design, pooling assessments, extrapolation, and ongoing monitoring.
Design and analyze analytical method bridging, transfer, qualification, and validation studies; establish acceptance criteria and evaluate equivalence, comparability, precision, accuracy, linearity, range, robustness, and intermediate precision.
Lead statistical planning and analysis for analytical and product comparability assessments related to process changes, manufacturing-site transfers, scale changes, method changes, and post-approval activities.
Provide statistical support for analytical control strategies, critical quality attribute assessments, process characterization, process validation, continued process verification, and product quality reviews.
Apply appropriate statistical methods to CMC datasets, including regression, analysis of variance, mixed models, equivalence testing, multivariate analysis, design of experiments, control charts, capability analysis, and risk-based sampling.
Support deviations, out-of-specification and out-of-trend investigations, root-cause assessments, CAPAs, and change controls with objective statistical analysis and clear interpretation.
Author and review statistical analysis plans, protocols, reports, technical memoranda, procedures, regulatory submission sections, and responses to health authority questions.
Ensure statistical approaches align with applicable ICH guidance, global regulatory expectations, cGMP requirements, data-integrity principles, and internal quality standards.
Partner with external CDMOs, CROs, and testing laboratories on study designs, data standards, analyses, deliverables, and timelines; critically review vendor analyses and resolve technical issues.
Develop fit-for-purpose statistical tools, templates, standards, and governance approaches to improve consistency, efficiency, traceability, and data-driven decision-making across CMC.
Communicate statistical concepts and conclusions to technical and non-technical stakeholders, influence cross-functional decisions, and present recommendations to senior leadership.
Manage multiple priorities in a fast-paced, resource-lean environment and perform other duties as assigned.