Senior Manager/Associate Director, Statistical Programming at Rapport Therapeutics in Boston, MA

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. The preferred location for this role is in Boston, MA with an onsite requirement of Monday-Wednesday every week. Your impact: The Senior Manager/Associate Director of Statistical Programming is responsible for providing clinical trial studies statistical programming leadership, strategic guidance and technical support of high-quality stats data outputs within Rapport’s Bipolar Mania program. This role is reporting directly to the head of statistical programming in the Biometrics group. Your day-to-day: Support Statistical Programming (SP) activities across all stages of clinical development (Phase I-IV), from protocol development design to clinical study report (CSR), health agency submission and post-marketing activities. Review and understand study documents, including the Protocol, electronic case Report Forms (eCRFs), Statistical Analysis Plans (SAPs), Data Transfer Specification, CDISC Standard Data Tabulation Model (SDTM) and Analysis Dataset Model (ADaM) specification and CSR. Serve as the clinical trial SP lead by developing, validating, and documenting SAS programs for SDTM, ADaM, and TFL outputs supporting CSRs, DSUR/IB updates, publications, and ad hoc, ISS and ISE deliverables. Manage outsourcing strategy and oversee deliverables from CROs and external vendors. Ensure compliance with industry standards (CDISC, ICH, FDA/EMA guidance) and company SOPs. Provide programming oversight for regulatory submissions (e.g., NDA/BLA/MAA), including eCTD packages, define.xml, and reviewer guides (cSDRG and ADRG). Engage the development and implementation of programming standards, automation tools, and quality control processes. Collaborate with Biostatistics leadership to ensure integration of statistical and programming workflows. Collaborate with statistical programmers at all levels to foster a strong, supportive, and motivated programming team. Contribute to cross-functional initiatives to improve data quality, efficiency, and innovation in clinical development. Must-Haves: Master’s or Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field. 8-10 years of experience in statistical programming within the biotech/pharmaceutical/CRO industry Title and compensation commensurate with experience and education Expert-level proficiency in SAS (Base, Macro, STAT, GRAPH) and strong experience with CDISC standards (SDTM, ADaM) in clinical trials. Strong SP clinical trial study project management skills and ability to manage multiple priorities in a fast-paced environment. In-depth knowledge of clinical trial processes, GCP, regulatory requirements (FDA, EMA), and ICH guidelines. Experience managing and developing high-performing teams,