---
title: 'Associate Director, CMC Statistics at Summit Therapeutics'
canonical: 'https://feeny.ai/job/associate-director-cmc-statistics-summit-therapeutics-princeton-3a8xzxfc71fh'
type: 'job'
last_seen: '2026-11-06'
---

# Associate Director, CMC Statistics at Summit Therapeutics

- **Company:** Summit Therapeutics
- **Location:** Princeton, NJ
- **Compensation:** $180k–$200k
- **Posted:** 2026-10-19
- **Last confirmed live:** 2026-11-06
- **Apply:** https://job-boards.greenhouse.io/summittherapeutics/jobs/4453207009

## Job description

About Summit:

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.

Colorectal Cancer (CRC)

- 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.

Experience, Education, and Specialized Knowledge and Skills

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.

## Key Competencies

- 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. This is the pay for this position

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 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 recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

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.

## About Summit Therapeutics

## Company Overview
- **One-liner**: Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on discovering, developing, and commercializing novel bispecific antibody therapies, with its lead candidate ivonescimab targeting PD-1 and VEGF for multiple solid tumors.
- **Entity Type**: Public (NASDAQ: SMMT)
- **Headquarters**: Miami, Florida, USA (with additional offices in Palo Alto, CA; Princeton, NJ; Oxford, UK; and Dublin, Ireland)
- **Founded**: 2003
- **Founders**: Not publicly disclosed on the company website; the company was founded in 2003.

## Core Business
- **Primary industry**: Biopharmaceuticals / Oncology
- **Target customers**: B2B (healthcare providers, patients, and caregivers) with a focus on resolving serious unmet medical needs in oncology
- **Mission statement**: "To resolve serious, unmet medical needs for the betterment of overall human health." [smmttx.com](https://smmttx.com/company/about-us/default.aspx)

## Products & Services
- **Ivonescimab (SMT112)**: A novel, potential first-in-class investigational bispecific antibody targeting both PD-1 and VEGF. It is designed to combine immunotherapy (PD-1 blockade) with anti-angiogenesis (VEGF blockade) into a single molecule. Currently being studied in several global Phase 3 clinical trials for non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and head and neck squamous cell carcinoma (HNSCC). Licensed from Akeso, Inc. (HKEX: 9926.HK) for territories including the U.S., Canada, Europe, Japan, Latin America, the Middle East, and Africa. [smmttx.com](https://smmttx.com/pipeline/default.aspx)

## Market Standing
- **Valuation/Market Cap**: Approximately $2.7 billion (as of recent data) [linkedin.com](https://www.linkedin.com/company/summit-therapeutics)
- **Key Metric**: Annual revenue of approximately $705,000 (reported). The company is pre-commercialization and heavily investing in R&D. Total funding raised since IPO (2015) is not disclosed, but the company has a strong cash position from equity offerings.
- **Notable Investors/Partners**: Akeso, Inc. (key licensing partner for ivonescimab). The company is publicly traded with institutional and retail investors.
- **Growth Signals**: 
  - Headcount grew 72.5% year-over-year to 244 employees. [linkedin.com](https://www.linkedin.com/company/summit-therapeutics)
  - Multiple global Phase 3 trials actively recruiting (HARMONi, HARMONi-3, HARMONi-7, HARMONi-GI3, ILLUMINE).
  - Over 4,000 patients have been treated with ivonescimab across all clinical trials globally. [smmttx.com](https://smmttx.com/pipeline/default.aspx)
  - Achieved Great Place to Work® Certification. [smmttx.com](https://smmttx.com/careers/careers-overview/default.aspx)

## Competitive Advantages
- **Novel Mechanism**: Ivonescimab is a first-in-class bispecific antibody targeting both PD-1 and VEGF simultaneously, potentially offering superior efficacy and fewer side effects compared to combination therapies.
- **Speed and Execution**: The company emphasizes "high-speed execution in commercialization" and has rapidly initiated multiple Phase 3 trials.
- **Global Reach**: Licensed territories cover major markets (U.S., Canada, Europe, Japan, Latin America, Middle East, Africa) with a strong partner (Akeso) in the rest of the world.
- **Strong Balance Sheet**: With a $2.7B market cap and public listing, the company has access to capital markets to fund its pipeline.

## Strategic Focus
- **Current priorities**: Advancing ivonescimab through Phase 3 clinical trials across multiple solid tumor indications (NSCLC, CRC, HNSCC), with the goal of regulatory approval and commercialization.
- **Future direction**: Expanding the pipeline into additional solid tumors and leveraging the bispecific platform for future therapies. The company is focused on becoming a leading oncology player.
- **Near-term milestones**: Data readouts from ongoing Phase 3 trials, potential regulatory submissions, and building commercial infrastructure.

## Why Work Here
- **Culture**: The company has achieved Great Place to Work® Certification, indicating a positive, supportive, and fulfilling work environment. Core values include Commitment to People, Integrity, Passion for Excellence, Purposeful Urgency, Accountability, and Collaboration. [smmttx.com](https://smmttx.com/careers/careers-overview/default.aspx)
- **Work Environment**: Fast-paced, high-energy atmosphere focused on innovation and collaboration. The company emphasizes "making a significant difference in patients’ lives."
- **Benefits (U.S.)**: 
  - 401(k) with 6% employer match
  - Employee Stock Purchase Plan (ESPP) with 15% discount up to the annual federal limit
  - Flexible Spending Account
  - Commuter Benefit
  - Onsite lunch provided
- **Benefits (U.K.)**: 
  - Private Medical Insurance
  - Employee Assistance Program
  - Life Assurance Policy
  - Company Pension Contributions
  - ESPP
- **Remote/Hybrid Policy**: Not explicitly stated, but multiple office locations suggest a hybrid or on-site presence is expected for many roles.
- **Open Roles**: 25 active job postings (as of recent data) including Senior Director of Sales Operations, Clinical Scientists, Medical Science Liaisons, and Drug Product MSAT roles. [greenhouse.io](https://job-boards.greenhouse.io/summitherrapeutics)
- **Headcount Growth**: 72.5% year-over-year growth signals a scaling organization with opportunities for career advancement.

## Sources
1. [smmttx.com - About Us](https://smmttx.com/company/about-us/default.aspx)
2. [smmttx.com - Investor Relations Overview](https://www.smmttx.com/overview/default.aspx)
3. [smmttx.com - Pipeline](https://smmttx.com/pipeline/default.aspx)
4. [smmttx.com - Careers Overview](https://smmttx.com/careers/careers-overview/default.aspx)
5. [linkedin.com - Summit Therapeutics Company Page](https://www.linkedin.com/company/summit-therapeutics)
6. [greenhouse.io - Summit Therapeutics Careers](https://job-boards.greenhouse.io/summitherrapeutics)

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