Associate Director, Biostatistics

Job not on LinkedIn

🕒 March 25

🇺🇸 United States – Remote

💵 $190k - $210k / year

⏰ Full Time

🟠 Senior

👔 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

• Serve as the study-level biostatistician for oncology clinical trials • Review protocols and conduct sample size calculations • Develop statistical analysis plans, data presentation plans, and Data Monitoring Committee charters • Review study documents, including CRFs, ADaM specifications, statistical outputs, protocols, and vendor data transfer specifications • Provide statistical support throughout oncology clinical studies • Collaborate with clinical operations, data management, and CROs on CRFs, database design, and data quality plans • Review clinical data accuracy, perform statistical analyses, apply appropriate statistical methods, and interpret study results • Collaborate with clinical teams to produce interim reports and final clinical study reports • Contribute to manuscripts for publication and ensure accurate statistical reporting • Develop and implement statistical methodologies to enhance study design and analysis • Review and analyze safety reporting, biomarker analyses, and other clinical trial monitoring aspects • Define required resources for assigned work • Help develop and implement department policies, standards, and procedures • Adhere to regulatory requirements, statistical principles, industry standards, and company SOPs

🎯 Requirements

• Ph.D. in Statistics, Biostatistics or equivalent area with 6+ years biopharmaceutical industry experience required; an MS degree in a related discipline with extensive industry and leadership experience (8+ years) can be considered • Strong proficiencies in biostatistics software and tools, such as SAS and 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 • Ability to effectively multi-task and manage time-sensitive and highly confidential documents • Ability to communicate effectively and articulate complex ideas in an easily understandable way • Ability to work in a fast-paced, demanding and collaborative environment

🏖️ Benefits

• Potential bonus • Stock • Benefits • Other applicable variable compensation