Senior Manager/Associate Director, Biostatistics

The role

This person will support the statistical design, execution, analysis, and reporting of clinical trials across development programs. They will work with cross-functional study teams to provide statistical input and oversee CRO biometrics deliverables.

What you will do

• 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.
• 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.
• Specify randomization schedules and support testing of their implementation.
• 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.

Required qualifications

• PhD in statistics, biostatistics, or a related field.
• Typically 8+ years 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.
• Working knowledge of FDA and ICH regulations and guidelines.
• 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 written communication skills.
• Ability to build effective cross-functional relationships and work collaboratively with internal colleagues, CROs, and external vendors.

Nice to have

• 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.
• experience with gene/cell therapy programs is desirable.

About the company

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The company uses base editing technology to advance a diversified portfolio of base editing programs.