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. 

The Role

Seaport Therapeutics is hiring a Director, Biostatistics to serve as the statistical scientific lead for one or more clinical development programs spanning Phase 1–3 within the Biometrics function. Reporting to the VP, Head of Biometrics, this role will provide strategic statistical leadership and serve as an independent statistical authority, shaping development strategies and representing Biostatistics in regulatory interactions, while also performing and guiding hands-on analysis across the clinical portfolio.

In the near term, the role will focus on leading statistical strategy, trial design, and CRO oversight for active clinical programs, ensuring regulatory defensibility and submission readiness. Over time, this leader will help build a strong statistical culture, mentor junior team members, and serve as a key contributor to the Biometrics leadership team as the organization scales.

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 3–4 days per week.

Key Responsibilities

Statistical Scientific Leadership

• Serve as the program‑level statistical lead with end‑to‑end accountability for trial design, analysis, interpretation, and reporting across multiple studies.
• Proactively identify, evaluate, and implement appropriate and innovative statistical methodologies aligned with clinical objectives, regulatory expectations, and risk profile.
• Provide expert judgment on complex statistical issues including multiplicity, missing data, intercurrent events, estimands, sensitivity analyses, and data interpretation.
• Conduct literature review, methodological research, and external benchmarking to support design decisions and defend approaches scientifically.

Clinical Trial Design & Analysis

• Lead the design of clinical trials, including sample size and power calculations; endpoint and estimand strategy (ICH E9(R1)); adaptive, Bayesian, or novel designs where appropriate; and simulation studies to evaluate operating characteristics.
• Translate clinical development questions into statistically sound and efficient designs.
• Author and/or review statistical sections of protocols, SAPs, TFL shells, and clinical study reports, ensuring scientific rigor and regulatory readiness.

Regulatory Strategy & Agency Interaction

• Lead statistical contributions to regulatory interactions (IND/CTA amendments, End‑of‑Phase meetings, Type C, NDA/BLA submissions).
• Prepare and defend statistical approaches in briefing documents, response letters, and meetings with FDA, EMA, and other global health authorities.
• Serve as the statistical lead in addressing regulatory questions, objections, and post‑submission requests, including development of additional analyses as required.

Hands‑On Analysis & Interpretation

• Perform and/or closely guide hands‑on statistical analyses using SAS and R, including ad hoc analyses for safety, efficacy, and decision‑making.
• Ensure analyses are reproducible, traceable, and aligned with agreed‑upon statistical principles.
• Partner with clinical and safety teams to support ongoing data monitoring and signal evaluation.

CRO & Vendor Oversight

• Provide scientific oversight of external CROs and vendors for biostatistics, programming, and data management activities.
• Review and quality‑check SDTM/ADaM datasets, analysis outputs, and define.xml for scientific accuracy and regulatory compliance.
• Ensure end‑to‑end traceability from raw data through analysis and reporting.

Cross‑Functional Collaboration & Influence

• Partner closely with Clinical Development, Regulatory Affairs, Clinical Operations, Pharmacovigilance, and Translational teams.
• Clearly communicate statistical concepts, risks, and recommendations to non‑statistical audiences.
• Mentor junior statisticians and programmers informally; contribute to building a strong statistical culture as the organization scales.

Qualifications

• PhD in Statistics or Biostatistics (or closely related quantitative field with equivalent depth).
• 10+ years of pharmaceutical/biotechnology experience providing biostatistical leadership across clinical development.
• Demonstrated ability to function as a scientific statistical authority, resolving complex design and analysis challenges independently.
• Deep knowledge of regulatory statistical guidance and expectations, including ICH E9, E9(R1), multiplicity, missing data, adaptive designs, and sensitivity analyses.
• Proven experience leading statistical aspects of regulatory submissions and agency interactions.
• Hands‑on expertise in SAS and R, including simulations and advanced analyses.
• Strong understanding of CDISC standards (SDTM, ADaM, Define‑XML) and regulatory traceability.
• Excellent written and verbal communication skills; ability to influence and defend positions with senior stakeholders.
• Experience in CNS/psychiatry or related therapeutic areas 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. $198,000-$240,000. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

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) 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.