Overview
The Senior Manager, Biostatistics provides statistical leadership for complex clinical studies in cell therapy oncology programs. This role is responsible for study design, statistical analysis, interpretation of results, and communication of statistical findings. Working independently with minimal supervision, the Senior Manager, Biostatistics serves as the lead statistician for assigned studies, collaborates with cross-functional project teams, and oversees statistical activities performed by contract research organizations (CROs) to ensure high-quality and timely deliverables.
Essential Functions and Responsibilities
- Serves as lead statistician for one or more clinical studies and may support program-level statistical strategy.
- Leads statistical activities for assigned studies and collaborates with statistical programmers and CRO partners to ensure timely delivery of high-quality statistical outputs.
- Authors and reviews statistical sections of study protocols, statistical analysis plans, clinical study reports, regulatory submission documents, and publications including abstracts and posters.
- Maintains current knowledge of statistical methodologies, regulatory guidance, and industry best practices relevant to oncology drug development.
- Contributes to process improvements, standards development, and statistical best practices within the Biostatistics function.
- Works effectively within cross-functional teams to address study-level operational and scientific challenges.
Required Education, Skills, and Knowledge
- Ph.D. in Statistics, Biostatistics, or related field with 3–5 years of relevant industry experience, or M.S. degree with 6–8 years of relevant industry experience.
- Strong experience supporting oncology clinical development programs, including design and analysis of early- and late-phase clinical trials.
- Sound knowledge of theoretical and applied statistics, including survival analysis methods, analyses on patient-reported outcome, and health economics.
- Proficiency in SAS; familiarity with R is highly desirable.
- Working knowledge of FDA, EMA, and ICH statistical guidance; experience supporting regulatory submissions including NDA, BLA, or MAA preferred.