Senior Director, Biostatistics

Rhythm Pharmaceuticals•Boston, MA

5d•$210,000 - $300,000•Hybrid

About The Position

Rhythm is seeking a Senior Director, Biostatistics to join our Biostatistics team in a highly visible strategic leadership role supporting important clinical development programs. This individual will serve as the lead statistician for assigned programs, with the opportunity to shape statistical strategy for programs that have the potential to make a meaningful difference for patients with rare neuroendocrine diseases. The role may also contribute to other clinical programs as business needs arise, providing flexibility and broad exposure across Rhythm’s development portfolio. Reporting to the Vice President, Head of Biostatistics & Statistical Programming, this individual will partner across clinical, regulatory, safety, data management, programming, and medical writing/publications teams to provide strategic guidance, scientific judgment, and hands-on biostatistical expertise. The ideal candidate is an independent, collaborative, and solutions-oriented leader who thrives in a dynamic, nimble biotech environment where business priorities may evolve quickly and sound judgment, flexibility, and clear communication are essential.

Requirements

10+ years of biostatistics experience in the pharmaceutical or biotechnology industry, including experience supporting clinical development programs.
Strong understanding of statistical concepts and clinical trial methodologies, with the ability to apply them thoughtfully to real-world development challenges.
Proficiency with SAS and R; experience with sample size software such as EAST preferred.
Familiarity with CDISC requirements, including SDTM and ADaM standards.
Demonstrated ability to manage multiple priorities, projects, and timelines while maintaining strong attention to quality.
Ability to contribute beyond biostatistics by engaging in broader clinical, regulatory, and safety discussions.
Excellent communication skills, with the ability to explain complex statistical concepts clearly to cross-functional and non-statistical audiences.

Nice To Haves

PhD in statistics, biostatistics, or a related quantitative discipline strongly preferred.
Preferred experience thriving in a dynamic, nimble biotech environment where priorities may shift quickly and flexibility, proactive communication, and sound judgment are important to success.

Responsibilities

Serve as the lead statistician for assigned clinical programs, providing biostatistical strategy and leadership across clinical development plans, study design, sample size and power calculations, protocols, statistical analysis plans (SAPs), TLFs, data analyses, and interpretation of results.
Contribute biostatistical expertise to other clinical programs as needs arise, supporting a flexible, portfolio-oriented approach in a dynamic biotech environment.
Collaborate with cross-functional partners to help shape study strategy, support strong study execution, and ensure statistical considerations are clearly integrated into clinical plans and deliverables.
Prepare and review statistical content for key clinical and regulatory documents, including protocols, clinical study reports, integrated summaries of safety and efficacy, and other submission-related materials.
Oversee statistical vendors and review deliverables to ensure high-quality, accurate, and consistent outputs.
Work closely with statistical programmers to review key efficacy and safety outputs, support quality control, and help resolve data or analysis issues.
Support interim analyses, DSMB meetings, ad hoc analyses, and other statistical activities that advance clinical program needs.
Contribute to statistical components of global regulatory submissions, including relevant sections of CTD Modules 2.5, 2.7, and 5.
Help ensure statistical analyses and results are clearly and accurately presented in INDs, NDAs, BLAs, MAAs, J-NDAs, and other regulatory submissions.
Support preparation of regulatory briefing materials and meeting documents, as needed.
Contribute to scientific publications, presentations, and other external communications by supporting statistical strategy, analyses, interpretation, and review of results.
Partner with data management on case report forms (CRFs), data management plans, edit checks, and related data review activities.
Contribute to the development and improvement of statistics SOPs and departmental processes.
Bring pragmatic, solutions-oriented leadership to a fast-paced biotech setting, helping teams adapt plans and priorities as clinical, regulatory, and business needs evolve.