Summit Therapeutics, Inc. · 20 hours ago
Principal Statistical Analyst
Palo Alto, CA
Full-time
Onsite
Senior Level, Lead/Staff
$175K/yr - $205K/yr
7+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company dedicated to improving quality of life and addressing unmet medical needs. The Principal Statistical Analyst will support and lead statistical programming activities for clinical trial data, collaborating with various teams to ensure compliance and quality of deliverables.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
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
Consolidate heterogeneous data source (e.g. clinical study databases, external databases, real world data) to prepare analysis-ready datasets supporting a particular project, study deliverable
Work closely with Biostatistician to implement CDISC SDTM and ADAM specification datasets
Perform compliance check and resolve any compliance issue during the process
Create documentation for regulatory filings including reviewers guides and data definition documents and ensure compliance per FDA guideline
Perform data analysis, statistical analysis, generate safety and efficacy tables, figures and listings using Base SAS, SAS macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/OD
Review Data Management Plan, Data monitoring plan and edit check specification
Implement data monitoring listings and SAS edit check to support team data monitoring
Evaluate scope of work for project or ad hoc requests on resource allocation, timeline buildup, and become the stakeholder on delivery
Validate work of other programmer/analysts at CRO or in-house to ensure appropriate validation process
Create, debug, validate or maintain company level macros that streamline repetitive operations to increase programming efficiency
Act as a liaison in study team between statistical programming, and other functional teams as needed
Leads or participates in the development of standard operating procedures (SOP)
Work on improving the efficiency and quality of existing workflows and mentors Statistical Programmers and Statistical analysts
All other duties as assigned
Qualification
Required
Bachelor's or Master's degree in Biostatistics, statistics, computer science or related field
Minimum 7+ years Pharmaceutical/Biotech programming experience. Experience working with Oncology trials preferred
Solid knowledge on CDISC standards including (SDTM, ADaM)
Good understanding and hands on experience on programming support for data monitoring and data clean/query process
Good understanding on clinical data coding dictionaries (MedDRA and WHODD)
High degree of technical competence and communication ability, both oral and written. Competent in SAS programming and Macro development
Working knowledge of current regulatory requirements and ICH guidance with deep understanding on clinical trial compliance requirements; Knowledge of Pinnacle 21
Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA, NDA/BLA or other regulatory filling experience, including ISS or ISE experience
The ability to work well under pressure and shifting priorities, both as a team leader and as a team member
The ability to plan, execute and manage project resources, timeline, and delivery with good skill on setting priorities
Ability to proactively identify and address project uncertainties to minimize risk
Strong problem solving and analytical skills
Ability to communicate clearly both oral and written
Preferred
Experience working with Oncology trials preferred
Fluency in 2 or more or relevant programming languages, such as R, Python will be plus
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
The Motley Fool
2026-01-13
Company data provided by crunchbase