Summit Therapeutics, Inc. · 11 hours ago
Director, Biostatistics
Menlo Park, CA
Full-time
Onsite
Director/Executive
$163K/yr - $191K/yr
6+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life through clinical studies in oncology. The Director of Biostatistics will serve as the study-level biostatistician, providing statistical support for clinical studies, conducting sample size calculations, and developing statistical analysis plans while collaborating with cross-functional teams to ensure data accuracy and regulatory compliance.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Provide statistical support to clinical development through the conduct of clinical studies in oncology
Conduct sample size calculations and develop statistical analysis plans (SAPs), data presentation plans, and DMC charters
Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan
Review study documents (e.g., protocol, vendor data transfer specifications, ADaM specifications, statistical outputs) for clinical trials in oncology
Review the accuracy of clinical data, perform statistical analysis, ensure the application of appropriate statistical methods, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final clinical study reports
Contribute to the preparation of manuscripts for publication, ensuring accurate statistical reporting of research findings
Develop and implement new statistical methodologies that enhance study design and analysis
Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring
Independently defines required resources for assigned work, seeking advice as needed
Work with department leader to develop and implement department policies, standards and procedures
Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and company SOPs
Qualification
Required
Ph.D. in Statistics, Biostatistics or equivalent area with 6+ years biopharmaceutical industry experience required
MS degree in related discipline with extensive industry and leadership experience (8+ years) can be considered
Strong proficiencies in software and other tools typically used by Biostatistics (e.g. SAS, R)
Good understanding of clinical trial processes and statistical programming requirements
Working knowledge of ICH, FDA and GCP regulations and guidelines
Attention to detail, accuracy and confidentiality
Clear and concise oral and written communication skills
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
Work in a fast-paced, demanding and collaborative environment
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 (2)
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