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Seaport Therapeutics · 1 day ago

Director, Statistical Programming

Boston, MA

Full-time

Onsite

Director/Executive

$198K/yr - $233K/yr

10+ years exp

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines. They are seeking a Director of Statistical Programming to build and lead the Statistical Programming function within the Biometrics department, focusing on vendor governance and ensuring high-quality, submission-ready deliverables.

BiotechnologyPharmaceuticalTherapeutics

H1B Sponsor Likely

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

Qualification

SAS programmingStatistical programmingCDISC standardsR programmingPeople managementClinical developmentTeam buildingTherapeutic area experienceCommunicationCollaboration skillsLeadership skills

Required

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

Preferred

Therapeutic area experience in CNS/neuropsychiatry is a plus; passion for Seaport's patient-centric mission is essential

Company

Seaport Therapeutics

Seaport Therapeutics operates as a clinical stage biopharmaceutical company.

Founded in 2024

Boston, Massachusetts, USA

51-200 employees

https://seaporttx.com/

H1B Sponsorship

Seaport Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2024 (1)