Senior Director of Biostatistics
Confidential
Senior Director of Biostatistics
About the Company
Well-funded clinical-stage biotechnology company advancing next-generation autoimmune CAR-T therapies.
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is in search of a Senior Director of Biostatistics to provide strategic and operational statistical leadership for its clinical development portfolio. The successful candidate will be the lead statistical expert, working closely with clinical, regulatory, and executive teams to drive study design, data analysis, and decision-making. This role is pivotal in ensuring the success of the company's cutting-edge cell therapy pipeline, particularly in the areas of autoimmune diseases, hematology, and oncology. Key responsibilities include serving as the statistical lead for multiple clinical programs, providing input into protocol design, and leading statistical analyses and interpretation of clinical trial data. The role also involves managing CROs, ensuring compliance with regulatory standards, and mentoring junior team members. Applicants for the Senior Director of Biostatistics position at the company should hold a PhD or Master's degree in biostatistics, statistics, or a related quantitative discipline, with a minimum of 10 years' experience in clinical biostatistics within the biotech or pharmaceutical industry. The ideal candidate will have a proven track record in leading statistical strategy from study design to regulatory submission, strong knowledge of FDA, EMA, ICH, and CDISC requirements, and experience in managing CRO and vendor relationships. Proficiency in SAS is required, with R experience being preferred. A background in cell therapy, CAR-T, immunology, autoimmune disease, hematology, or oncology, as well as experience in early-phase and complex clinical development programs, is also highly valued. The role demands a professional who is comfortable in a fast-paced, collaborative environment and can balance strategic leadership with hands-on execution.
Hiring Manager Title
Head of Biometrics
Functions
- Data Management/Analytics
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