Director, Statistical Programming

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com . Seaport Therapeutics is hiring our first in-house Statistical Programming leader to build and lead the Statistical Programming function within the Biometrics department. Reporting to the VP, Head of Biometrics, this Director will provide strategic oversight of CRO/vendor programming activities, perform hands-on programming in SAS and R, and ensure high-quality, submission-ready deliverables that meet CDISC and global regulatory standards. In the near term, the role will focus on vendor governance, thorough review/QC of datasets and TLFs, and support for regulatory interactions, publications, and ongoing medical/safety monitoring. Longer term, this leader will establish processes and SOPs, recruit and develop a high-performing team, and serve as a key member of the Biometrics leadership team driving continuous improvement. The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a “we own it” mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston’s Seaport area, with a strong preference for being onsite 4 days per week. Key Responsibilities: Lead the Statistical Programming function for Seaport Therapeutics; serve as programming representative on study and program teams and within the Biometrics leadership group. Provide strategic oversight and day-to-day governance of CROs and external programmers, including scope planning, timelines, quality metrics, and issue escalation. Perform hands-on programming in SAS or R to review/QC vendor deliverables, develop analysis datasets (SDTM/ADaM), and generate tables, listings, and figures (TLFs). Ensure compliance with CDISC standards (SDTM, ADaM), FDA/EMA/ICH guidance, and submission requirements (e.g., define.xml, reviewer’s guides, eCTD packages). Support regulatory interactions (IND, NDA/BLA/MAA), including ad hoc analyses, briefing package outputs, and responses to information requests. Partner with Biostatistics, Data Management, Clinical, and Safety to enable medical and safety monitoring, signal detection, and data-driven decision-making across ongoing trials. Establish and maintain programming processes, SOPs, work instructions, and reusable libraries/macros; champion automation, reproducibility, and audit readiness. Recruit, manage, mentor, and develop a team of statistical programmers as the portfolio grows; manage contractors/FSPs and oversee performance and career development. Drive continuous improvement across standards, tools, and infrastructure (SAS/R environments, version control, code review practices) in collaboration with IT and QA. Plan and manage resources and budgets for programming activities; contribute to vendor selection, governance frameworks, and performance/quality measures for delivery quality and timeliness. Represent Statistical Programming in inspections and audits; ensure documentation completeness and compliance with 21 CFR Part 11, GCP, data privacy, and company SOPs. Qualifications: Advanced degree (MS/PhD)