Overview
Senior Director, Biostatistics at Rapport Therapeutics. This role shapes the design, analysis, and interpretation of clinical trial data for precision neuromedicine programs. Reporting to the VP of Biometrics, you will collaborate with multidisciplinary teams to ensure statistical rigor and the highest standards of data integrity throughout the drug development process.
Responsibilities
- Contribute to the design of clinical trials, including writing or reviewing statistical sections of protocols and statistical analysis plans (SAPs).
- Perform and validate statistical analyses of clinical trial data using SAS and / or R in accordance with regulatory and internal standards.
- Support the generation of tables, listings, and figures (TLFs) and contribute to the interpretation of results.
- Collaborate with Clinical and Regulatory teams to provide statistical input to study reports, regulatory submissions, and publications.
- Participate in the development and review of case report forms (CRFs) and data management plans to ensure accurate data collection aligned with study objectives.
- Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA).
- Assist in the development, validation, and documentation of statistical methodologies and processes.
- Oversee and manage external CROs and vendors to ensure high-quality and timely deliverables.
- Participate in cross-functional team meetings, providing statistical support and insights to influence decision-making.
- Ensure all statistical activities comply with regulatory guidelines and company policies.
- Assist in the preparation of regulatory documents, including Investigational New Drug (IND) applications and New Drug Applications (NDAs).
- Contribute to development of internal statistical processes, SOPs, and initiatives.
Qualifications
PhD with 12+ years of experience or MS with 15+ years for Senior Director in statistics, biostatistics, or a closely related discipline within the pharmaceutical or biotech sector.CNS therapeutic area experience is a plus.Skilled in scientific programming including SAS or R, or Python 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.Strong attention to detail, organizational skills, and ability to manage multiple projects in a fast-paced environment.Proven collaboration, leadership, and organizational skills.Significant experience with global regulatory agency interactions.Experience in resource planning, recruiting, and defining organizational needs with senior leaders.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. 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 and development.We\'re bicoastal. Whether you\'re in the lab in San Diego or hybrid in Boston, we make the most of our time together.Competitive benefits, including unlimited PTO, a lifestyle spending account, commuting reimbursement, and more.You get to be YOU! Show up as you are and make every day count.Your Compensation
We expect the hiring range for this role to be $270,000 to $295,000. The actual offer will reflect factors including relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, Rapport offers a comprehensive benefits package and transparency around salary ranges for every level within the company.
Hybrid Work Environment
We prioritize in-person connection with Rapptors. Team members are onsite at our Boston office on Tuesday and Wednesday. Starting January 2026, onsite days will shift to three days per week to enhance collaboration and innovation.
Rapport Therapeutics is an equal opportunity employer and will not discriminate on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by law.
Note to Employment Agencies
Please do not forward agency resumes. The company will not be responsible for fees related to unsolicited resumes.
CCPA disclosure notice can be found here.
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