Senior Manager/Associate Director, Biostatistics

<div class="content-intro"><p></p> <p><strong>Company Overview:</strong></p> <p>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.</p> <p></p></div><p></p> <p><strong>Position Overview:</strong></p> <p>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.</p> <p><strong>Responsibilities:</strong></p> <ul> <li>Serve as the study-level statistician for one or more clinical studies and provide oversight of CRO biometrics deliverables.</li> <li>Support clinical development teams in robust study design and execution, with a focus on efficient and data-driven decision making.</li> <li>Contribute to clinical protocol development, including design evaluations and drafting of protocol statistical sections.</li> <li>Lead or contribute to the development of statistical analysis plans, TLF shells, data specifications, data monitoring charters, and related study documents.</li> <li>Generate or review TLFs and perform ad hoc analyses as needed.</li> <li>Review CRF design, data management plans, and data transfer plans to ensure data collection supports trial objectives and planned statistical analyses.</li> <li>Specify randomization schedules and support testing of their implementation as needed.</li> <li>Contribute to the review, interpretation, and communication of clinical trial data.</li> <li>Support the development of clinical study reports, regulatory documents, publications, manuscripts, posters, and abstracts.</li> <li>Support regulatory submissions and responses to regulatory questions, as needed.</li> <li>Provide statistical requirements and oversight to statistical programmers and external vendors.</li> <li>Work collaboratively and communicate effectively with statistical programming, data management, clinical operations, clinical development, regulatory, and other cross-functional partners.</li> </ul> <p><strong>Qualifications:</strong></p> <ul> <li>Ph.D. in statistics, biostatistics, or a related field with a minimum of 4 years of relevant experience in the pharmaceutical or biotechnology industry.</li> <li>Experience serving as a study-level statistician or statistical lead for clinical trials.</li> <li>Strong knowledge of statistical methods and clinical trial design for rare disease and/or gene/cell therapy clinical trials is desirable.</li> <li>Experience with statistical simulations, Bayesian methods, observational studies, and/or real-world data is desirable.</li> <li>Experience supp