Senior Manager/Associate Director, Biostatistics

Rapport Therapeutics; Massachusetts; Hybrid; USD 200,000 - 220,000; Full time

Job summary

Rapport Therapeutics seeks a Senior Manager / Associate Director of Biostatistics to shape the design, analysis, and interpretation of clinical trial data for our CNS programs. Reporting to the Head of Biostatistics, you will collaborate with multidisciplinary teams to ensure statistical rigor and data integrity throughout drug development.

You will lead protocol development, SAP, SDTM/ADaM datasets, provide strategic statistical leadership, manage CROs, and support regulatory submissions.

Qualifications

• PhD with 3+ years biostatistics experience or MS with 6+ years in biostatistics.
• Experience in CNS drug development and survival/adaptive design is highly desirable.
• Proficiency in SAS or R for data analysis, graphing, and simulation.
• Strong knowledge of clinical trial design and regulatory guidelines (FDA/EMA/ICH).
• CDISC SDTM/ADaM expertise and data standards familiarity.

Responsibilities

• Lead statistician on multiple studies; oversee protocol development and SAP for regulatory submissions.
• Provide strategic statistical leadership across development programs; influence study design and data-driven decisions.
• Support SDTM/ADaM data planning and delivery; ensure CDISC compliance.
• Interpret results for study reports, regulatory submissions, and publications with cross-functional teams.
• Perform and validate statistical analyses using SAS and/or R.
• Contribute to CRF development and data management plans; coordinate with CROs/vendors.
• Serve as biometrics representative on cross-functional teams.

Skills

Statistical leadership

Regulatory strategy

Communication to non-stat audiences

Project management

Education

PhD with 3+ years biostatistics experience

MS with 6+ years biostatistics experience

Tools

SAS

R

Job description

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we’re driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we’re doing this with extraordinary science and awesome people (affectionately called Rapptors).

Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials in primary generalized tonic-clonic seizures (PGTCS) and bipolar disorder.

The strength of Rapport comes from our Rapptors – who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you’re as excited about this opportunity as we are!

We anticipate hiring for this role in mid-Q4.

Your Impact

Rapport is seeking a Senior Manager / Associate Director of Biostatistics who will have a hands‑on role in shaping the design, analysis, and interpretation of clinical trial data for our Bipolar Mania program. Reporting to the Head of Biostatistics, you will collaborate closely with multidisciplinary teams to advance groundbreaking therapies, ensuring statistical rigor and the highest standards of data integrity throughout the drug development process.

Your Day-to-day

• Working as a leading statistician on multiple studies/projects. Oversee the production of protocol development (study design, endpoint selection, sample size calculation and statistical methods) and Statistical Analysis Plan (SAP) that lead to comprehensive clinical study reports suitable for regulatory submissions.
• Provide strategic statistical leadership across development programs, influencing study design, data‑driven decision‑making, and regulatory strategies.
• Support statistical programming to plan, execute and deliver SDTM and ADaM datasets, tables, listings, and figures (TLFs). Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA).
• Provide statistical input and the interpretation of results to clinical study reports, regulatory submissions documents, and publications, in collaboration with the clinical, regulatory, and medical affairs teams.
• Perform and validate statistical analyses of clinical trial data using SAS and/or R in accordance with regulatory and internal standards.
• Participate in the development and review of case report forms (CRFs) and data management plans to ensure accurate data collection aligned with study objectives.
• Oversee and manage external CROs and vendors to ensure high‑quality and timely deliverables.
• Serve as the biometrics representative on cross‑functional team, providing statistical support and insights to influence decision‑making.

Must-Haves

• Senior Manager: PhD with 3+ or MS with 6+ years of biostatistics experience
• Associate Director: PhD with 6+ years or MS with 9+ years of biostatistics experience
• Experience in the CNS drug development and expertise in survival analysis and/or adaptive design is highly desirable
• Skilled in scientific programming including SAS or R for data analysis, graphing, and simulation
• Comprehensive knowledge of clinical trial design, advanced statistical analysis methods, and familiarity with regulatory guidelines (FDA, EMA, ICH)
• Extensive knowledge of CDISC standards (SDTM, ADaM) and industry best practices for data collection, analysis, and reporting
• Ability to communicate complex statistical concepts clearly to non‑statistical audiences.
• Ability to manage multiple projects in a fast‑paced environment, flexibility to adapt to changing priorities and timelines
• Ability to effectively collaborate with internal stakeholders and manage the statistical work of external stakeholders/vendors

What Makes Rapport Special

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas — we work as a team.
• We have FUN. We hire smart, dedicated, down‑to‑earth people that you’ll enjoy spending time with.
• Leadership that CARES — about you, your growth + development.
• We're bicoastal. Whether you're in the lab full‑time in San Diego or taking advantage of a more hybrid work schedule in Boston — we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for the role to be $200,000 to $220,000 for Associate Director level. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

CCPA disclosure notice can be found here.