Executive Director, Biostatistics

About Summit

Ivonescimab, known as SMT
112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:

• HARMONi:
  Phase III trial evaluating ivonescimab combined with chemotherapy versus placebo plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC patients who progressed after 3rd generation EGFR TKI (e.g., osimertinib).
• HARMONi-3:
  Phase III trial evaluating ivonescimab combined with chemotherapy versus pembrolizumab combined with chemotherapy in first-line metastatic NSCLC.
• HARMONi-7:
  Phase III trial evaluating ivonescimab monotherapy versus pembrolizumab monotherapy in first-line metastatic NSCLC with high PD-L1 expression.

Ivonescimab is an investigational therapy not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. It was approved for marketing authorization in China in May 2024 and granted Fast Track designation by the US FDA.

The Executive Director of Biostatistics serves as the Biostatistics Lead for multiple oncology projects, providing strategic and technical leadership, statistical support, and regulatory submissions. They collaborate with clinical science, regulatory and other functions on clinical development plans, authorship of key clinical, regulatory, statistical documents, and ensuring high-quality delivery and interpretation of clinical data. The Executive Director develops and implements biostatistics department policies, represents biostatistics in interactions with CROs, IRBs, and regulatory agencies, and has direct supervisory responsibilities for internal staff or external consultants.

• Serve as the Biostatistics Lead for multiple oncology projects.
• Provide strategic and technical leadership and statistical support for late-stage oncology trials.
• Ensure high quality of regulatory authority documents, including clinical protocols, statistical analysis plans, study reports, briefing books, submissions, and safety reports.
• Collaborate with cross-functional teams to ensure accurate interpretation of study results and delivery of high-quality study reports and publications.
• Write and review sections of meeting packages and assist in regulatory submissions.
• Lead assessment and implementation of novel statistical methodologies.
• Represent the biostatistics function within cross-functional teams.
• Collaborate with the department leader to develop and implement policies, standards, and procedures.
• Develop relationships with key stakeholders across Regulatory, Clinical Development, Clinical Operations, and Research.
• Assess and manage CROs and vendors on scope, timelines, deliverables, and budgets.
• Keep up to date with FDA and EMA regulations, emerging trial designs, and communicate updates to stakeholders.
• Participate in meetings with FDA and other health authorities.
• Provide mentorship and coaching to direct reports.
• Perform additional duties as assigned.

• Ph.D. in Statistics, Biostatistics, or equivalent with 15+ years biopharmaceutical industry experience, or MS with 18+ years experience.
• Minimum 3+ years of experience in team leadership and managing direct reports.
• 10+ years of experience in oncology clinical trials, including trial design and execution in late-stage trials.
• Extensive knowledge of clinical trial development and statistical methodologies for trial design and execution, regulatory submissions, and late-stage oncology trials.
• Experience providing statistical support for Medical Affairs and Market Access activities preferred.
• Experience interacting with health authorities.
• Comprehensive knowledge of ICH, FDA, GCP regulations and guidelines.
• Excellent organizational, critical thinking, problem-solving, and ability to multitask.
• Effective communication of complex ideas in an understandable way.
• Ability to work independently and in fast-paced, collaborative environments.

The pay range for this role is $224,000–$285,000 annually, with additional bonus, stock, benefits and/or variable compensation. Actual compensation is based on skill set, experience, certifications, and work location.

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