Associate Director, Statistical Programmer
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-03-01
Listing for:
Connect Life Sciences
Full Time
position Listed on 2026-03-01
Job specializations:
-
IT/Tech
Data Analyst, Data Scientist, Data Science Manager, Data Security
Job Description & How to Apply Below
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
- 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
Position Requirements
10+ Years
work experience
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