Serves as statistical lead for clinical studies and program activities, supporting study design, sample size calculations, SAPs, analyses, TLFs, interim analyses, regulatory submissions, and interpretation of results. Collaborates with clinical, regulatory, safety, data management, programming, and external vendor teams. Reviews statistical outputs, ensures quality and compliance, contributes to inspection readiness, and supports process improvements in a fast-paced 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 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.
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 $160,000 - $240,000. 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 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.
Responsibilities and Duties
- 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.
Qualifications and Skills
- 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.
- Experience contributing to IND, NDA, BLA, MAA, J-NDA, or other regulatory submission deliverables is preferred but not required.
- 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.
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 $160,000 - $240,000. 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
Similar Jobs
Biotech
Lead statistical strategy and execution for clinical development programs. Oversee study design, SAP authoring, data analysis, TFL/CDISC deliverables, CRO/vendor oversight, regulatory interactions, and interpretation of results to support submissions and program decisions.
Top Skills:
Cdisc
Biotech • Pharmaceutical
Lead study-level biostatistics for clinical trials: design, SAPs, TLFs, CRF and randomization review; oversee CRO biometrics and programmers; perform analyses, support regulatory submissions, and collaborate cross-functionally.
Top Skills:
AdamCdashRSASSdtm
Biotech • Pharmaceutical
Lead and perform advanced statistical analyses for clinical trials, observational and RWD studies. Author SAPs, TFL shells, and data dissemination plans. Guide cross-functional teams, mentor staff, review programming, contribute to CSRs and publications, and engage with regulators and payers. Independently drive study design, analysis methods, and project-level biostatistics decisions.
Top Skills:
RSAS
What you need to know about the Boston Tech Scene
Boston is a powerhouse for technology innovation thanks to world-class research universities like MIT and Harvard and a robust pipeline of venture capital investment. Host to the first telephone call and one of the first general-purpose computers ever put into use, Boston is now a hub for biotechnology, robotics and artificial intelligence — though it’s also home to several B2B software giants. So it’s no surprise that the city consistently ranks among the greatest startup ecosystems in the world.
Key Facts About Boston Tech
- Number of Tech Workers: 269,000; 9.4% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Thermo Fisher Scientific, Toast, Klaviyo, HubSpot, DraftKings
- Key Industries: Artificial intelligence, biotechnology, robotics, software, aerospace
- Funding Landscape: $15.7 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Summit Partners, Volition Capital, Bain Capital Ventures, MassVentures, Highland Capital Partners
- Research Centers and Universities: MIT, Harvard University, Boston College, Tufts University, Boston University, Northeastern University, Smithsonian Astrophysical Observatory, National Bureau of Economic Research, Broad Institute, Lowell Center for Space Science & Technology, National Emerging Infectious Diseases Laboratories
