Director, Biostatistics

🕒 March 24

🇺🇸 United States – Remote

💵 $203k - $253k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 45%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

🔥 Funding within the last year

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 Description

• 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

🎯 Requirements

• PhD and a minimum of 8+ years of experience or Masters (MS) and a minimum of 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, and etc. • Excellent written and verbal communication skills • Good working knowledge of ICH, FDA and GCP regulations and guidelines

🏖️ Benefits

• Bonus • Stock • Benefits and/or other applicable variable compensation