Director, Biostatistics (Hybrid)

Summit Therapeutics Sub, Inc. • Menlo Park, CA

436d • $228,000 - $252,000

About The Position

The Director of Biostatistics at Summit Therapeutics will serve as the project-level biostatistician, providing leadership within the biostatistics function. This role involves developing and executing statistical strategies, study designs, and analyses for clinical trials in oncology. The director will collaborate with clinical science and regulatory teams, author key documents, and ensure the delivery and interpretation of clinical data. Additionally, the position includes developing department policies and representing biostatistics in interactions with external partners and regulatory agencies.

Requirements

• A minimum of PhD 8+ or MS (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.
• Experience in organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA).
• In-depth knowledge of CDISC standards.
• Technical expertise and knowledge of experimental design and analyses using SAS, R, or EAST, etc.
• Excellent written and verbal communication skills.
• Good working knowledge of ICH, FDA and GCP regulations and guidelines.

Responsibilities

• Provide technical leadership and statistical support to clinical development through the design and conduct of clinical studies in oncology.
• Support/contribute to protocol development to ensure appropriateness of trial design, sample size, and propose the use of meaningful and efficient statistical methodologies.
• Lead development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses.
• Review the accuracy of clinical data, perform statistical analysis, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final reports, and publications.
• Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes.
• Review vendor data transfer specifications and ADaM programming specifications.
• Lead assessment and introduction of novel statistical methodologies to implement solutions.
• Represent biostatistics function or biometrics department in cross function teams.
• Work with department leader to develop and implement department policies, standards and procedures.
• Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan.
• Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets.
• Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
• Attend meetings with FDA or other health authorities to ensure ongoing agreement on project development.
• All other duties as assigned.

Benefits

• 401(k) 6% Match
• 401(k) matching
• Employee stock purchase plan
• Flexible spending account
• Health insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree