Beam Therapeutics
Senior Manager/Associate Director, Biostatistics
Cambridge, MA · Director · Full-time
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About the role
- Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines.
- To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities.
- This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs.
Responsibilities
- Support clinical development teams in robust study design and execution, with a focus on efficient and data-driven decision making.
- Contribute to clinical protocol development, including design evaluations and drafting of protocol statistical sections.
- Lead or contribute to the development of statistical analysis plans, TLF shells, data specifications, data monitoring charters, and related study documents.
- Generate or review TLFs and perform ad hoc analyses as needed.
- Review CRF design, data management plans, and data transfer plans to ensure data collection supports trial objectives and planned statistical analyses.
- Specify randomization schedules and support testing of their implementation as needed.
- Support the development of clinical study reports, regulatory documents, publications, manuscripts, posters, and abstracts.
- Support regulatory submissions and responses to regulatory questions, as needed.
- Work collaboratively and communicate effectively with statistical programming, data management, clinical operations, clinical development, regulatory, and other cross-functional partners.
- Beam is seeking a Senior Manager/Associate Director, Biostatistics to support the statistical design, execution, analysis, and reporting of clinical trials across Beam's development programs.
Requirements
- Typically 8+ years with a minimum of 4 years of relevant experience in the pharmaceutical or biotechnology industry.
- Experience with statistical simulations, Bayesian methods, observational studies, and/or real-world data is desirable.
- Working knowledge of FDA and ICH regulations and guidelines
- experience with gene/cell therapy programs is desirable.
- Proficiency in SAS and/or R programming.
- Strong knowledge of clinical data standards, including CDASH, SDTM, and ADaM.
- PhD in statistics, biostatistics, or a related field.
- Experience serving as a study-level statistician or statistical lead for clinical trials.
- Strong knowledge of statistical methods and clinical trial design for rare disease and/or gene/cell therapy clinical trials is desirable.
- Ability to work independently, manage priorities, and deliver high-quality work in a fast-paced environment.
- Strong verbal and written communication skills.
- Ability to build effective cross-functional relationships and work collaboratively with internal colleagues, CROs, and external vendors.
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
Nice to have
- Experience supporting regulatory submissions, including NDA/BLA/MAA activities, is preferred.
Compensation
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.
This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.