Senior Manager​/Associate Director, Biostatistics

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.

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.

• 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.

• 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…