Summit Therapeutics, Inc. · 2 months ago
Executive Director, Biostatistics
Menlo Park, CA
Full-time
Onsite
Director/Executive
$224K/yr - $285K/yr
15+ years expSummit Therapeutics, Inc. is focused on developing innovative therapies, including Ivonescimab for non-small cell lung cancer. The Executive Director of Biostatistics will lead multiple oncology projects, providing strategic and technical leadership in statistical strategies and regulatory submissions.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Serve as the Biostatistics Lead for multiple oncology projects
Provide strategic and technical leadership, along with statistical support, to clinical development in the design and conduct of late-stage oncology trials
Provide strategic input and guidance to ensure the 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 high-quality study reports and publications
Write and review sections of meeting packages, and assist in the development and review of other documents required for regulatory submissions and processes
Lead the assessment and implementation of novel statistical methodologies to drive solutions
Represent the biostatistics function or biometrics department in cross-functional teams
Collaborate with the department leader to develop and implement policies, standards and procedures
Develop strong, collaborative relationships with key business stakeholders, including project leaders in Regulatory, Clinical Development, Clinical Operations, Research and other functions
Assess and manage CROs and other vendors, including scope-of-work, timelines, deliverables, and budgets
Stay up to date with FDA and EMA regulations, guidance, emerging trial designs for marketing authorization, and communicate relevant updates to key stakeholders
Participate in meetings with FDA and other health authorities to ensure alignment on project development
Provide mentorship and coaching to direct reports to help them reach their full potential
All other duties as assigned
Qualification
Required
Ph.D. in Statistics, Biostatistics or equivalent area with 15+ years biopharmaceutical industry experience or MS degree in related discipline with extensive industry and leadership experience with 18+ years biopharmaceutical industry experience required
A minimum of 3+ years of experience in team leadership and managing direct reports is required
10+ years of experience in oncology clinical trials, including trial design and execution, with a strong background in late-stage clinical trials
Extensive knowledge of clinical trial development and statistical methodologies related to trial design and execution is required, with experience in late-stage oncology trials and regulatory submissions essential
Comprehensive knowledge of ICH, FDA, and GCP regulations and guidelines, with strong, well-rounded technical skills
Excellent organizational skills
Critical thinking, problem solving, ability to work independently
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
Communicate effectively and articulate complex ideas in an easily understandable way
Prioritize conflicting demands
Work in a fast-paced, demanding and collaborative environment
Preferred
Experience in providing statistical support for Medical Affairs and Market Access activities is highly preferred
Experience interacting with health authorities
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Board Member
Recent News
2025-12-09
2025-12-05
Company data provided by crunchbase