Senior Director, Statistical Programming

Added
1 hour ago
Type
Full time
Salary
Salary not provided

Related skills

cross-functional collaboration leadership sas cdisc sdtm

📋 Description

  • Provide strategic leadership for Statistical Programming across therapies
  • Lead global programming team and ensure high-quality outputs for regulatory submissions
  • Oversee SDTM, ADaM, and TLF deliverables under CDISC
  • Collaborate with Biostatistics, Data Management, Clinical Ops, and Regulatory teams
  • Drive process improvements and adoption of new technologies/tools
  • Support regulatory submissions (NDA, BLA, MAA) and health authority queries

🎯 Requirements

  • Master’s or PhD in Statistics, Biostatistics, or related field
  • 12–18+ years in Statistical Programming in pharma/CRO
  • SAS programming; CDISC SDTM/ADaM; regulatory submissions
  • Proven leadership of large, global programming teams
  • Strong knowledge of clinical trial processes and data standards
  • Experience interacting with regulatory authorities preferred
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