Leads biostatistical strategy for clinical development programs, including study design, sample size calculations, protocols, SAPs, analyses, TLFs, regulatory submissions, interim analyses, and interpretation of results. Collaborates with clinical, regulatory, safety, data management, programming, and medical writing teams; oversees statistical vendors; supports publications and process improvements; and provides strategic leadership in a dynamic biotech environment.
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
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.
Responsibilities and Duties
Qualifications and Skills
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $210,000 - $300,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
Inherent in our core values is the commitment to act ethically and with integrity in all we do.
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
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.
Responsibilities and Duties
- 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.
Qualifications and Skills
- PhD in statistics, biostatistics, or a related quantitative discipline strongly preferred.
- 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.
- 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.
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $210,000 - $300,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
- We are committed to advancing scientific understanding to improve patients’ lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
Inherent in our core values is the commitment to act ethically and with integrity in all we do.
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
Rhythm Pharmaceuticals Boston, Massachusetts, USA Office
222 Berkeley Street, Boston, MA, United States, 02116
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