Senior Director, Statistical Programming

New

Skills

ADaM CDISC SDTM Clinical Trials Cross-Functional Collaboration Data Management Pharmacovigilance Regulatory Compliance R Programming SAS Programming Statistical Analysis

The Senior Director of Statistical Programming will play a critical role in supporting the statistical programming function for clinical trials. This position involves implementing standard operating procedures (SOPs), leading programming activities for projects and submissions, and ensuring high-quality deliverables. The successful candidate will manage external vendors, collaborate with cross-functional teams, and contribute to the development of data review and reporting tools.

Key Responsibilities
  • Support the statistical programming function by implementing SOPs for clinical trials.
  • Lead programming activities for projects and submissions ensuring high quality.
  • Manage CROs and external vendors for quality and compliance.
  • Collaborate with Biostatistics, Data Management, Clinical Ops, Regulatory, and Pharmacovigilance teams.
  • Develop data review, reporting tools, and statistical applications with cross-functional teams.
  • Review SAS programs (SDTM, ADaM, and TFLs) and SAPs/CRFs.
Required Skills & Qualifications
  • Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or related field.
  • 12–15 years of clinical trial programming experience in biotech or pharma with leadership roles.
  • Advanced SAS programming skills; experience with R or other programming languages is a plus.
  • Strong knowledge of CDISC SDTM/ADaM and controlled terminology.
  • Experience mentoring programmers and managing CROs; ability to collaborate across functions.
  • Familiarity with AI in drug development, automation, and cloud platforms.

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Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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