{"id":3034815,"url":"https://alion.io/job/smmttx-associate-director-cmc-statistics","title":"Associate Director, CMC Statistics","company":{"id":21096,"name":"Summit Therapeutics","domain":"smmttx.com","url":"https://alion.io/company/smmttx","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Princeton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":180000,"max":200000,"currency":"USD","period":"year","gross":null,"usd_annual":200000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design of Experiments","optional":false},{"name":"GMP","optional":false},{"name":"JMP","optional":false},{"name":"Minitab","optional":false},{"name":"Python","optional":false},{"name":"SAS","optional":false},{"name":"Tableau","optional":true}],"status":"live","first_seen_at":"2026-10-19T14:48:55Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-11-03T13:00:20Z","board_verified":true,"closed_at":null,"days_open":14,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":14},"description":"About Summit:\nSummit 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.\nSummit’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:\nNon-small Cell Lung Cancer (NSCLC)\nHARMONi: 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.\n\nHARMONi-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.\n\nHARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.\n\nColorectal Cancer (CRC)\nHARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.\n\nIvonescimab 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.\nAssociate Director, CMC Statistics\nJob Title: Associate Director, CMC Statistics\nDepartment: CMC\nLocation: Princeton, NJ (Onsite; four days per week)\nReports To: Executive Director, Analytical Sciences\nOverview of Role\nThe 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.\nRole and Responsibilities\nServe as the CMC statistical subject matter expert for biologic drug substance and drug product development, registration, commercialization, and lifecycle management.\nDevelop 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.\nLead statistical evaluation of stability data, including trend analysis, shelf-life and retest-period modeling, protocol design, pooling assessments, extrapolation, and ongoing stability monitoring.\nDesign 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.\nLead 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.\nProvide statistical support for analytical control strategies, critical quality attribute assessments, process characterization, process validation, continued process verification, and product quality reviews.\nApply 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.\nSupport deviations, out-of-specification and out-of-trend investigations, root-cause assessments, CAPAs, and change controls through objective statistical analysis and clear interpretation.\nAuthor and review statistical analysis plans, protocols, reports, technical memos, procedures, regulatory submission sections, and responses to health authority questions.\nEnsure statistical approaches align with applicable ICH guidance, global regulatory expectations, cGMP requirements, data-integrity principles, and internal quality standards.\nPartner 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.\nDevelop fit-for-purpose statistical tools, templates, standards, and governance approaches that improve consistency, efficiency, traceability, and data-driven decision-making across CMC.\nCommunicate complex statistical concepts and conclusions clearly to technical and non-technical stakeholders, influence cross-functional decisions, and present recommendations to senior leadership.\nManage multiple priorities in a fast-paced, resource-lean environment and perform other duties as assigned.\nExperience, Education, and Specialized Knowledge and Skills\nRequired Qualifications\nAdvanced 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.\nMinimum of 10 years of industry experience applying statistics to biologics CMC activities in a biopharmaceutical or biotechnology setting.\nDirect, substantial experience with specification setting, stability trending and shelf-life assessment, analytical method bridging, and comparability assessment is required.\nDemonstrated experience supporting biologic drug substance and drug product programs and working with analytical, manufacturing, quality, and regulatory data.\nStrong 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.\nExperience applying statistical principles to analytical method qualification, validation, transfer, lifecycle monitoring, and investigations.\nWorking knowledge of applicable ICH guidance, FDA and EMA expectations, cGMP requirements, and data-integrity standards for biologics development and commercialization.\nProficiency 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.\nExperience authoring or reviewing technical protocols, statistical analysis plans, reports, regulatory submission content, and health authority responses.\nExcellent written and verbal communication skills, with the ability to explain statistical concepts and business implications to non-statistical audiences.\nDemonstrated ability to work independently, exercise sound scientific judgment, influence cross-functional teams, and manage multiple priorities with high attention to quality and detail.\nPreferred Qualifications\nExperience with monoclonal antibodies, bispecific antibodies, or other complex biologics.\nExperience supporting late-stage development, BLA/MAA submissions, commercial readiness, process validation, PPQ, post-approval changes, and product lifecycle management.\nExperience operating in an outsourced or virtual development model with CDMOs, CROs, and external testing laboratories.\nExperience establishing CMC statistical standards, procedures, templates, analysis plans, or governance frameworks.\nFamiliarity with data visualization and reporting tools such as Spotfire, Tableau, or comparable platforms.\nKey Competencies\nScientific and statistical rigor with pragmatic, risk-based judgment.\nClear communication and the ability to translate data into actionable CMC decisions.\nCollaboration, influence, and stakeholder management across internal teams and external partners.\nProactive problem-solving, agility, and accountability in a dynamic environment.\nCommitment to quality, compliance, inclusion, and continuous improvement.\nWork Location and Travel\nThis 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.\nAdditional Information\nThe 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.\nSummit is an equal opportunity employer committed to fostering an inclusive workplace. Employment decisions are made without regard to any status protected by applicable law.\nThis is the pay for this position\nPay Transparency\n$180,000—$200,000 USD\nActual 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.\nSummit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at  to obtain prior written authorization before referring any candidates to Summit.\nSummit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. 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