Associate Director/Director, Biostatistics Job at Beam Therapeutics (Cambridge)

Associate Director/Director, Biostatistics

Beam Therapeutics

Location:
United States , Cambridge

Category:
Research and Development

Contract Type:
Not provided

Salary:

185000.00 - 260000.00 USD / Year

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Job Description:

Beam is seeking an Associate Director/Director of Biostatistics to provide the statistical strategic plan, design, execution, and reporting of clinical trials across Beam’s development programs. The ideal candidate will work closely with the Head of Biometrics and play a key role in the statistical strategy for clinical development programs and provide oversight to CROs to ensure timely execution of the clinical trials.

Job Responsibility:

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

Requirements:

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
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
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

Nice to have:

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

Additional Information:

Job Posted:
January 23, 2026

Employment Type:

Fulltime

Work Type:

Hybrid work

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Associate Director/Director, Biostatistics

Beam Therapeutics

Location:
United States , Cambridge

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 23, 2026

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