Director, Statistical Programming

Director, Statistical Programming

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) in Statistics, Biostatistics, Computer Science, Mathematics, or related discipline; BS with strong relevant experience considered.
• 10+ years of statistical programming experience in biotech/pharma/CRO settings, with 5+ years of people management.
• Expert hands-on proficiency in SAS (Base, Macro, STAT, GRAPH, SQL) and strong working knowledge of R; experience with Python is a plus.
• Demonstrated experience overseeing CROs/vendors and validating programming deliverables to CDISC standards (SDTM, ADaM).
• Proven contribution to global submissions (e.g., NDA/BLA/MAA), including submission-ready datasets, TLFs, define.xml, reviewer's guides, and CSR appendices.
• Strong understanding of clinical development processes, ICH/GCP, FDA/EMA guidelines, and 21 CFR Part 11 compliance.
• Track record of building teams, establishing SOPs and standards, and implementing automation and best practices for efficiency and quality.
• Excellent communication, collaboration, and leadership skills; ability to translate technical concepts for non-technical stakeholders.
• Therapeutic area experience in CNS/neuropsychiatry is a plus; passion for Seaport's patient-centric mission is essential.

At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is $198,000-233,000 with the final offer based on experience, market data, and internal equity. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.