ClinChoice

Associate Director, Statistical Programming

ClinChoice

full-time

Posted on:

Location Type: Hybrid

Location: Massachusetts • United States

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Job Level

Senior

About the role

  • Lead programming strategy across multiple clinical studies and development programs.
  • Oversee and manage internal programmers and external vendors/CRO partners.
  • Establish and maintain programming standards, processes, and best practices.
  • Support planning, timelines, and resourcing for all programming activities.
  • Provide oversight and hands-on support for the development and validation of SDTM, ADaM datasets.
  • Ensure all deliverables meet regulatory, statistical, and quality requirements.
  • Guide the implementation of programming workflows using SAS and/or R.
  • Drive automation, reproducibility, and process efficiency within the programming team.
  • Partner closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams.
  • Serve as a key programming representative in study team meetings.
  • Support regulatory submissions, including eCTD-ready deliverables, reviewer guides, and traceability documents.

Requirements

  • Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
  • 8–12+ years of experience in clinical programming within pharma/biotech or CRO.
  • Strong proficiency in SAS, with experience in R being a strong plus.
  • Expert-level knowledge of CDISC standards (SDTM, ADaM).
  • Experience managing or overseeing programming teams and external vendors.
  • Proven track record supporting regulatory submissions (FDA, EMA, PMDA, etc.).
  • Excellent communication, leadership, and project management skills.
Benefits
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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SASRCDISC standardsSDTMADaMprogramming standardsprogramming workflowsautomationprocess efficiencydata validation
Soft Skills
communicationleadershipproject management