Senior Manager or Associate Director, Biostatistics

Rapport Therapeutics•Boston, MA

13d•$190,000 - $220,000•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 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 precision neuromedicine programs. Reporting to the Senior Director 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.

Requirements

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
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.
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

Nice To Haves

CNS therapeutic area experience is a plus

Responsibilities

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.
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 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.