Director, Biostatistics

rapport Therapeutics•Boston, MA

72d•$235,000 - $295,000•Hybrid

About The Position

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 for neuropathic pain 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! Your Impact: Rapport is seeking a Director or Senior Director of Biostatistics who will have a pivotal role in shaping the design, analysis, and interpretation of clinical trial data for our precision neuromedicine programs. Reporting to the VP of Biometrics, 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.

Requirements

PhD with 10+ years of experience (12+ for Senior Director) OR MS with 12+ years of experience (15+ for Senior Director) in statistics, biostatistics, or a closely related discipline within the pharmaceutical or bio-tech sector.
Title and compensation commensurate with experience
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 with 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

Nice To Haves

CNS therapeutic area experience is a plus

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 manager 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

Benefits

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.

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