CMC Statistics Lead — Biologics, Regulatory Strategy

Summit Therapeutics, Inc.; Princeton (NJ); On-site; USD 180,000 - 200,000; Full time

Job summary

Summit Therapeutics Inc. in Princeton, NJ, is seeking an Associate Director, CMC Statistics, to provide hands‑on statistical leadership across Chemistry, Manufacturing, and Controls activities.

The role partners with Analytical Sciences, MSAT, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external CDMOs/CROs to develop scientifically sound, phase‑appropriate, and regulatory‑defensible statistical strategies for drug substance and drug product development.

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 quantitative discipline.
• 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.
• Strong command of statistical methods relevant to CMC, including regression, ANOVA, mixed models, equivalence and non‑inferiority approaches, tolerance intervals, control charts, capability analysis, multivariate methods, and design of experiments.
• Proficiency with one or more statistical software platforms such as JMP, SAS, R, Python, or Minitab, with the ability to produce reproducible, traceable analyses and effective data visualizations.

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 establishment and justification of release and stability acceptance criteria, control limits, tolerance intervals, and clinically and process‑relevant decision rules.
• Lead statistical evaluation of stability data, including trend analysis, shelf‑life and retest‑period modeling, protocol design, pooling assessments, extrapolation, and ongoing stability monitoring.
• Design and analyze analytical method bridging, transfer, qualification, and validation studies; define acceptance criteria and assess equivalence, comparability, precision, accuracy, linearity, range, robustness, and intermediate precision.
• Lead statistical planning and analysis for analytical and product comparability assessments associated with 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 methods such as regression, analysis of variance, mixed models, equivalence testing, multivariate analysis, design of experiments, control charts, capability analysis, and risk‑based sampling to CMC datasets.
• Support deviations, out‑of‑specification and out‑of‑trend investigations, root‑cause assessments, CAPAs, and change controls through objective statistical analysis and clear interpretation.
• Author and review statistical analysis plans, protocols, reports, technical memos, 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 to align 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 that improve consistency, efficiency, traceability, and data‑driven decision‑making across CMC.
• Communicate complex statistical concepts and conclusions clearly 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.

Skills

Statistics leadership

Biostatistics

Regulatory data analysis

Cross-functional collaboration

Communication

Project leadership

Education

PhD in Statistics or related field

Tools

SAS

R

Python

JMP

Job description

Summit Therapeutics Inc. in Princeton, NJ, is seeking an Associate Director, CMC Statistics, to provide hands‑on statistical leadership across Chemistry, Manufacturing, and Controls activities.

The role partners with Analytical Sciences, MSAT, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and external CDMOs/CROs to develop scientifically sound, phase‑appropriate, and regulatory‑defensible statistical strategies for drug substance and drug product development.