Beam Therapeutics · 17 hours ago
Associate Director/Director, Biostatistics
Cambridge, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$185K/yr - $260K/yr
7+ years expBeam Therapeutics is a biotechnology company focused on precision genetic medicines. They are seeking an Associate Director/Director of Biostatistics to lead the statistical strategy for clinical trials and ensure the timely execution of clinical development programs.
BiotechnologyGeneticsMedicalTherapeutics
Responsibilities
Responsible for the statistical strategy for one or more clinical programs/studies and for providing oversight of CRO biometrics deliverables
Support clinical development team to enable robust study design and execution with a focus on innovative and efficient quantitative decision making
Contribute to clinical protocol development, including design evaluations and authoring of protocol statistical sections
Work with study team to develop SAP, data specification, TLF shells, and data monitoring charters etc. and generate TLFs and perform ad hoc analysis as needed
Review CRF design, data management plan, and data transfer plans to ensure data collection meet the trial objectives and requirements of statistical analyses
Specify randomization schedules and test their implementations as needed
Contribute to the review and interpretation of data analyses from clinical trials and to the development of CSRs, regulatory documents and support publications, manuscripts, posters and abstracts
Support regulatory submissions and interactions with regulatory agencies
Provide requirements and oversight to statistical programmers
Works collaboratively and communicates effectively with Statistical programming, Data Management, clinical operations, clinical development, Regulatory and other functions
Qualification
Required
Ph.D. in statistics or biostatistics with a minimum of 7 years' post-doctoral experience in pharmaceutical/biotech industry with prior project leadership or equivalent experience
In-depth knowledge of statistical methods and trial designs for rare disease and/or gene and cell therapy clinical trials
Proficient in SAS and R programming
Strong knowledge of data standards, including CDASH, SDTM, and ADaM
Must be self-motivated, and able to work independently and effectively with colleagues and vendors and demonstrate excellent verbal and written communication skills
Ability to prioritize and manage timelines and shifting priorities within a fast-paced company environment
Ability to build cross-functional relationships and work collaboratively across functions
Preferred
Extensive experience in statistical simulations, Bayesian statistical design and analysis and experience in observational studies and/or real world data (RW) are desirable
Extensive experience in NDA/BLAs, MAAs and other regulatory interactions preferred
Strong knowledge of FDA and ICH regulations and guidelines, experience and knowledge of gene/cell therapy are desirable
Company
Beam Therapeutics
Beam Therapeutics is a biotechnology company developing precision genetic medicines through the use of base editing technology.
501-1000 employees
H1B Sponsorship
Beam Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (12)
2022 (9)
2021 (7)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.19B2025-03-10Post Ipo Equity· $500M
2021-01-19Post Ipo Equity· $260M
2020-02-11Post Ipo Equity· $207M
Leadership Team
John Evans
CEO
Christine Bellon
Chief Legal Officer
Recent News
2026-01-23
2026-01-13
Company data provided by crunchbase