Director, Biostatistics

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.