Biostatistics Associate Director — Clinical Lead

Rhythm Pharmaceuticals, Inc; Boston (MA); Hybrid; USD 160,000 - 240,000; Full time

Job summary

Rhythm Pharmaceuticals, Inc. seeks an Associate Director, Biostatistics to lead statistical activities for clinical development programs in a hybrid Boston setting.

You will partner with cross-functional teams to design robust studies, perform complex analyses, and ensure clear interpretation of results for regulatory submissions. The role requires rigorous statistical expertise (PhD or MS with extensive experience), proficiency in SAS and R, and familiarity with CDISC standards.

Qualifications

• PhD or MS with significant clinical trial experience in biopharma, biotech, or CRO settings.
• Proficiency in SAS and R; familiarity with CDISC SDTM/ADaM standards.

Responsibilities

• Serve as the statistical lead for assigned clinical studies or program activities, including study design, sample size and power calculations, SAPs, and data analyses.
• Collaborate with cross-functional teams to incorporate statistical considerations into clinical plans and deliverables.
• Prepare and review statistical content for protocols, CSRs, and regulatory submissions.
• Oversee statistical vendors and ensure quality control of outputs.
• Work with statistical programmers to review efficacy and safety outputs and resolve issues.
• Support interim analyses and regulatory submissions as needed.
• Contribute to components of CTD sections and regulatory materials.
• Partner with data management on CRFs and data review activities.

Skills

SAS

R

Statistical analysis

Study design & power

Communication

Independent work

Education

PhD in Statistics/Biostatistics or related

MS in Statistics/Biostatistics or related with 8+ years

Tools

EAST

Job description

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

• 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 involvesome 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 theTop Places to Workin Massachusetts.