Senior Manager/Associate Director, Biostatistics

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 written communication skills.
• Able to build effective cross-functional relationships and work collaboratively with internal colleagues, CROs, and external vendors.

Pay

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.

Beam Pay Range $155,000—$225,000 USD

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