Connect Life Sciences · 1 day ago
Associate Director, Statistical Programmer
Boston, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
10+ years expConnect Life Sciences is a company focused on advancing clinical research, and they are seeking an Associate Director, Statistical Programmer. The role involves leading statistical programming activities, ensuring the quality of deliverables, and collaborating with study teams and external partners.
EmploymentLife ScienceStaffing AgencyTraining
Hiring Manager
Beth Ward
Responsibilities
Lead statistical programming activities across multiple studies or an entire clinical program, ensuring timely, accurate, and submission‑ready deliverables
Provide oversight of vendor‑produced SDTM, ADaM, and TLFs, ensuring technical quality, consistency, and regulatory compliance
Collaborate closely with internal study teams and external partners to align on timelines, priorities, and quality expectations
Oversee CRO deliverables, ensuring clear documentation, traceability, and adherence to standards
Develop, validate, and maintain SDTM and ADaM datasets and TLFs to support data review, CSRs, annual reports, publications, and ad hoc data requests
Serve as a programming subject‑matter expert for regulatory submissions (e.g., FDA, EMA), including support of electronic submission standards (eCTD)
Coordinate and manage data transfers and delivery of required outputs as a lead or supporting programmer
Review and contribute to key clinical and regulatory documents
Manage multiple priorities, proactively troubleshoot technical and project issues, and contribute to process and infrastructure improvements within the department
Evaluate and implement innovative tools and programming technologies to improve efficiency, quality, and scalability
Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis
Qualification
Required
MS (or equivalent) in Statistics, Biostatistics, Computer Science, or a related field
10+ years of statistical programming experience in the pharmaceutical or biotechnology industry, including support of late‑phase (Phase II/III) clinical trials
Proven experience overseeing CROs and external vendors, with accountability for quality, timelines, and deliverables
Deep hands‑on expertise with CDISC standards (SDTM, ADaM) and strong knowledge of regulatory submission requirements (e.g., NDA/MAA)
Demonstrated ability to independently deliver high‑quality analysis datasets and TLFs for both planned analyses and ad hoc data requests
Strong expertise in efficacy endpoint programming and analysis, with the ability to translate clinical objectives into analysis‑ready datasets and meaningful outputs
Company
Connect Life Sciences
Connect Life Sciences is a recruitment agency that provides staffing and connects talent and opportunity within Life Sciences.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Andrew Doucet
Vice President, Life Sciences Consulting, Co-Founder
Recent News
2025-09-17
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