Associate Director / Director, Statistical Programming

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 :

The Associate Director or 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.

Must-Haves :

Title and level commensurate with experience

What makes Rapport special :

Your Compensation :

We get it. Compensation is an important part of your offer. You shouldn't be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for this role to be $180,000 to $200,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don't stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.

Hybrid Work Environment :

This role is based in Boston, MA. We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies : Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

CCPA disclosure notice can be found here.