Summit Therapeutics, Inc. · 9 hours ago
Director, Statistical Programming
Palo Alto, CA
Full-time
Onsite
Director/Executive
$203K/yr - $253K/yr
8+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company dedicated to improving quality of life through innovative clinical studies. The Director of Statistical Programming will oversee statistical programming projects, lead a team in developing and validating SAS programs for clinical trial data analysis, and ensure compliance with regulatory requirements.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Provides technical and/or operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions
Works closely with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs
Works closely with Data Management on cross-functional data review and the development and validation of CDISC SDTM specifications and datasets and define packages, may also support Drug Safety to support safety data review and reporting needs, and/or Clinical Pharmacology to support their dataset creation and analytic needs
Manages internal and vendor statistical programming support; Maintains strong collaboration and governance with preferred vendors
Writes SAS programs that produce or validate tables, listings, figures, and analysis datasets, in support of clinical studies or complex integrated analyses for submission
Performs, plans, and coordinates project work to ensure timely, quality delivery across multiple projects, or across a drug program
Writes specifications to describe programming needs, including development and maintenance of complex / ADaM specifications and reviewer guides
May lead the creation and validation of global macros or systems that streamline repetitive operations to increase programming efficiency
Provides input into, or leads general standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations)
Leads efforts to develop programming processes consistent with industry best practices
Reviews and provides expert input to DMP, eCRF specs, and other clinical data management documents; Reviews and provides expert input to statistical analysis plans and other related documents
Partners with or oversees CROs or Programming vendors to perform any of the above tasks
Qualification
Required
PhD with 8+ years of experience or MS with 11+ years of experience in statistics or biostatistics or related disciplines with clinical trials, pharmaceutical/biotech industry, or healthcare experience
Experience in supporting oncology phase II/III clinical studies
In-depth knowledge of CDISC standards
Technical expertise and knowledge of experimental design and analyses using SAS, R, or EAST, and etc
Excellent written and verbal communication skills
Good working knowledge of ICH, FDA and GCP regulations and guidelines
Strong computer and database skills
Attention to detail, accuracy and confidentiality
Clear and concise oral and written communication 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 organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA)
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
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