Associate Director, Biostatistics

🕒 March 24

🇺🇸 United States – Remote

💵 $174k - $203k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 56%

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2003

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.

📋 Description

• Serve as the project-level biostatistician and provide leadership within the biostatistics function for oncology clinical trials • Develop and execute statistical strategy, study design, statistical analyses, and regulatory submissions • Partner with clinical science, regulatory, and other team members on clinical development plans and key clinical, regulatory, and statistical documents • Develop and implement biostatistics department policies, standards, procedures, and work instructions • Represent biostatistics in interactions with CROs, institutional review boards, and regulatory agencies • Provide technical leadership and statistical support through clinical study design and conduct • Support protocol development, including trial design, sample size, and statistical methodologies • Lead statistical analysis plans, data presentation plans, clinical development plans, biometrics submission activities, and post-submission strategies/responses • Review clinical data, perform statistical analyses, interpret study results, and collaborate on interim reports, final reports, and publications • Write or review meeting-package sections and regulatory submission documents • Review vendor data transfer specifications and ADaM programming specifications • Lead assessment and introduction of novel statistical methodologies • Represent biostatistics or biometrics in cross-functional teams • Collaborate on CRFs, database design, and the overall data quality plan • Evaluate and manage CROs and 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 the FDA or other health authorities • Perform other duties as assigned

🎯 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 software and other tools typically used by Biostatistics, including 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

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