Associate Director, CMC Statistics

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

Job summary

Summit Therapeutics Inc. seeks an Associate Director, CMC Statistics to provide hands-on statistical leadership across Chemistry, Manufacturing, and Controls.

You will partner with Analytical Sciences, MSAT, Manufacturing, Quality, Regulatory Affairs, and CDMOs/CROs to craft robust statistical strategies for drug substance and product development, ensuring regulatory-defensible decisions. The role requires translating complex data into clear conclusions for global submissions, commercial

Qualifications

• Advanced degree (PhD/ScD or equivalent) preferred; master’s degree considered.
• Minimum of 10 years of industry experience applying statistics to biologics CMC activities.
• Experience with regulatory data, quality systems, and cross-functional collaboration.

Responsibilities

• Serve as the CMC statistics SME for biologic drug substance and product development, registration, and lifecycle management.
• Develop and execute statistical strategies for release criteria, stability, and control limits.
• Lead statistical evaluation of stability data and transfer/validation studies; support regulatory submissions.
• Collaborate with Analytical Sciences, MSAT, Manufacturing, QA, Regulatory, Supply Chain, and external CDMOs/CROs.

Skills

Statistical leadership

Biopharmaceutical statistics

Cross-functional collaboration

Regulatory data analysis

Education

PhD in Statistics/Biostatistics

Advanced degree (PhD/ScD) preferred; master’s considered

Tools

SAS

R

Python

JMP

Minitab

Job description

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. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Associate Director, CMC Statistics

Job Title: Associate Director, CMC Statistics
Department: CMC
Location: Princeton, NJ (Onsite; four days per week)
Reports To: Executive Director, Analytical Sciences

Overview of Role

The Associate Director, CMC Statistics, will provide hands-on statistical leadership across Chemistry, Manufacturing, and Controls (CMC) activities. This individual will partner 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. The role will be accountable for statistical support of specification setting, stability trending and shelf-life assessment, analytical method bridging and transfer, comparability assessments, method validation, process and product monitoring, investigations, and lifecycle management. The successful candidate will translate complex CMC datasets into clear conclusions, risk assessments, and recommendations that support global regulatory submissions, commercial readiness, and ongoing product control.

Role and 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.

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 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.
• 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, 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, with the 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, with the ability to explain statistical concepts and business implications to non-statistical audiences.
• Demonstrated ability to work independently, exercise sound scientific judgment, influence cross-functional teams, and manage multiple priorities with high attention to quality and detail.

Preferred Qualifications

• 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.
• Scientific and statistical rigor with pragmatic, risk-based judgment.
• Clear communication and the ability to translate data into actionable CMC decisions.
• Collaboration, influence, and stakeholder management across internal teams and external partners.
• Proactive problem-solving, agility, and accountability in a dynamic environment.
• Commitment to quality, compliance, inclusion, and continuous improvement.

Work Location and Travel

This position is based onsite in Summit’s Princeton, New Jersey office and requires in-office presence four days per week. Periodic travel may be required to support CDMO/CRO oversight, technical meetings, audits, inspections, regulatory interactions, or cross-functional workshops.

Additional Information

The pay range for this role will vary depending on location. Actual compensation packages are based on factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location. The total compensation package may also include bonus, stock, benefits, and/or other applicable variable compensation.

Summit is an equal opportunity employer committed to fostering an inclusive workplace. Employment decisions are made without regard to any status protected by applicable law.

Pay Transparency

$180,000 - $200,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit Therapeutics Inc.is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.