Senior Manager/Associate Director, Biostatistics

Company Overview: 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. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. 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. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. Position Overview: 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. The ideal candidate will work closely with cross-functional study teams to provide statistical input, contribute to study-level strategy, and oversee CRO biometrics deliverables to support timely and high-quality trial execution. Responsibilities: • Serve as the study-level statistician for one or more clinical studies and provide oversight of CRO biometrics deliverables. • 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. • Contribute to the review, interpretation, and communication of clinical trial data. • Support the development of clinical study reports, regulatory documents, publications, manuscripts, posters, and abstracts. • Support regulatory submissions and responses to regulatory questions, as needed. • Provide statistical requirements and oversight to statistical programmers and external vendors. • Work collaboratively and communicate effectively with statistical programming, data management, clinical operations, clinical development, regulatory, and other cross-functional partners. Qualifications: • Ph.D. in statistics, biostatistics, or a related field with a minimum of 4 years of relevant experience in the pharmaceutical or biotechnology industry. • 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. • Experience with statistical simulations, Bayesian methods, observational studies, and/or real-world data is desirable. • Experience supporting regulatory submissions, including NDA/BLA/MAA activities, is preferred. • 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. • Ability to work independently, manage priorities, and deliver high-quality work in a fast-paced environment. • Strong verbal and