Seaport Therapeutics

Director, Statistical Programming

Boston, MA · Director

Sponsorship not specified$198k-$233kDetected 21 days ago

PythonCode ReviewSQLGCPStatisticsRecruitingFDA RegulatorySASLeadershipCommunicationCollaborationBiostatistics

About the role

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs.
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.

Lead the Statistical Programming function for Seaport Therapeutics
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).
Support regulatory interactions (IND, NDA/BLA/MAA), including ad hoc analyses, briefing package outputs, and responses to information requests.
Establish and maintain programming processes, SOPs, work instructions, and reusable libraries/macros
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
Lead the Statistical Programming function for Seaport Therapeutics; serve as programming representative on study and program teams and within the Biometrics leadership group.
Establish and maintain programming processes, SOPs, work instructions, and reusable libraries/macros; champion automation, reproducibility, and audit readiness.

Advanced degree (MS/PhD) in Statistics, Biostatistics, Computer Science, Mathematics, or related discipline
10+ years of statistical programming experience in biotech/pharma/CRO settings, with 5+ years of people management.
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.
ability to translate technical concepts for non-technical stakeholders.
BS with strong relevant experience considered.
Demonstrated experience overseeing CROs/vendors and validating programming deliverables to CDISC standards (SDTM, ADaM).
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
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.

Expert hands-on proficiency in SAS (Base, Macro, STAT, GRAPH, SQL) and strong working knowledge of R
experience with Python is a plus.
Therapeutic area experience in CNS/neuropsychiatry is a plus
passion for Seaport's patient-centric mission is essential.

The expected salary range for this role is $198,000-233,000 with the final offer based on experience, market data, and internal equity.

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.
Partner with Biostatistics, Data Management, Clinical, and Safety to enable medical and safety monitoring, signal detection, and data-driven decision-making across ongoing trials.

This listing is sourced directly from Seaport Therapeutics's careers page and normalized into a canonical job model.