Associate Director/Director, Statistical Programming
Listed on 2026-03-01
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IT/Tech
Data Analyst, Data Scientist, Data Security, Data Science Manager
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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 ImpactThe Principal Statistical Programmer or Associate Director of Statistical Programming is responsible for providing clinical trial studies stat programming leadership, strategic guidance and technical support of high quality stats data output within Rapport’s clinical development programs. This role reports directly to the Head of Statistical Programming in the Biometric group’s.
Your Day-to-day- Lead Statistical Programming 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) and CSR.
- Have strong technical hands-on experience of SAS base/graph/stat programming skills on CDISC SDTM/ADaM specification, datasets and and TFL (tables, listings, figures) generation/validation.
- 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).
- Lead the development and implementation of programming standards, automation tools, and quality control processes.
- Serve as a subject matter expert for programming strategy, data standards, and regulatory expectations.
- Collaborate with Biostatistics leadership to ensure integration of statistical and programming workflows.
- Hire, manage and coach different level stat programmers to establish a strong and motivated statistical programming team.
- Manage outsourcing strategy and oversee deliverables from CROs and external vendors.
- Contribute to cross-functional initiatives to improve data quality, efficiency, and innovation in clinical development.
- 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 industry.
- Title and level commensurate with experience.
- Proven ability to build, lead, and develop high-performing programming teams, with a demonstrated track record of mentoring talent, fostering a collaborative culture, and aligning team objectives with broader organizational goals.
- Expert-level proficiency in SAS (Base, Macro, STAT, GRAPH) and experience with CDISC standards (SDTM, ADaM).
- Proven track record of supporting successful regulatory submissions (e.g., NDA, BLA, MAA).
- In-depth knowledge of clinical trial processes, GCP, regulatory requirements (FDA, EMA), and ICH guidelines.
- Strong project management skills and ability to…
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