Associate Director, Biostatistics

Rhythm Pharmaceuticals•Boston, MA

4d•$160,000 - $240,000•Hybrid

About The Position

Rhythm is seeking an Associate Director, Biostatistics to join our Biostatistics team and support important clinical development programs. Reporting to the Vice President, Head of Biostatistics & Statistical Programming, this individual will serve as a hands-on statistical lead for assigned studies or program activities, partnering across clinical, regulatory, safety, data management, and programming teams to support robust study design, high-quality analyses, and clear interpretation of results. The ideal candidate is an independent, collaborative, and solutions-oriented biostatistician who brings strong technical judgment, attention to quality, and the ability to contribute effectively in a dynamic, nimble biotech environment where priorities may evolve quickly.

Requirements

PhD in Statistics, Biostatistics, or a related quantitative discipline preferred, with approximately 5+ years of relevant clinical trial experience in biopharma, biotech, or CRO settings; or MS in Statistics, Biostatistics, or a related discipline with approximately 8+ years of relevant experience.
Strong understanding of statistical concepts and clinical trial methodologies, with the ability to apply them thoughtfully to practical development and analysis challenges.
Knowledge of the drug development process and experience supporting clinical studies across one or more phases of development.
Proficiency with SAS and R; experience with sample size software such as EAST preferred.
Familiarity with CDISC requirements, including SDTM and ADaM standards.
Ability to manage multiple priorities, projects, and timelines while maintaining strong attention to quality and detail.
Excellent communication, presentation, and report-writing skills, with the ability to explain complex statistical concepts clearly to cross-functional and non-statistical audiences.
Ability to work independently within established strategic direction, collaborate effectively across functions, and adapt to evolving priorities in a fast-paced biotech environment.

Nice To Haves

Experience contributing to IND, NDA, BLA, MAA, J-NDA, or other regulatory submission deliverables is preferred but not required.

Responsibilities

Serve as the statistical lead for assigned clinical studies or defined program activities, contributing to clinical development plans, study design, sample size and power calculations, protocols, statistical analysis plans (SAPs), TLFs, data analyses, and interpretation of results.
Collaborate with cross-functional partners to support study strategy, execution, and decision-making, ensuring statistical considerations are clearly incorporated into clinical plans and deliverables.
Prepare and review statistical content for protocols, clinical study reports, integrated summaries of safety and efficacy, and other submission-related or study-level documents.
Oversee statistical vendors for assigned deliverables, including review, validation, and quality control of outputs to ensure accuracy, consistency, and compliance with Rhythm standards.
Work closely with statistical programmers to review key efficacy and safety outputs, support dry runs and quality control, identify data or analysis issues, and help drive timely resolution.
Support interim analyses, DSMB meetings, ad hoc analyses, and other statistical activities required to advance clinical program needs.
Contribute to statistical components of global regulatory submissions, including relevant sections of CTD Modules 2.5, 2.7, and 5, as needed.
Support the presentation of statistical analyses and results in INDs, NDAs, BLAs, MAAs, J-NDAs, and other regulatory submissions or briefing materials.
Partner with data management on CRFs, data management plans, edit checks, data review activities, and related processes that support high-quality analysis outputs.
Contribute to departmental standards, templates, process improvements, and practical solutions that enhance quality, efficiency, and inspection readiness.