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Lead Statistical Programmer

Location

United States

Posted

94 days ago

Salary

0

No structured requirement data.

Job Description

Lead Statistical Programmer

Penfield Search Partners

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We are seeking a highly experienced Statistical Programmer to lead programming activities across global clinical studies. This role operates beyond executional programming, with responsibility for oversight of CRO deliverables, validation of outputs, and end-to-end accountability for statistical programming packages. - Lead statistical programming activities across global studies (EU and China exposure preferred) - Serve as primary programming lead in collaboration with Biostatistics - Develop, review, and validate SDTM and ADaM datasets in accordance with CDISC standards - Review specifications and proactively challenge inconsistencies in protocols, SAPs, and dataset definitions - Validate program outputs and ensure accuracy, quality, and regulatory compliance - Provide oversight and guidance to CRO partners, consolidating and communicating feedback effectively - Manage timelines, delivery packages, and milestone commitments - Contribute to continuous improvement of programming processes and standards Qualifications - Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related field - 5+ years of SAS programming experience within pharmaceutical/biotech - Strong understanding of statistical methods used in clinical trial analysis - Knowledge of Good Programming Practices and GCP - Preferred: Experience with R programming Requirements - Strong expertise in CDISC standards, including ADaM and SDTM - Demonstrated experience reviewing specs and ensuring high-quality, submission-ready deliverables - Experience validating CRO programming deliverables - Ability to operate with increased performance accountability and ownership - Strong CRO-facing communication and collaboration skills - Proven ability to manage multiple global studies simultaneously Time Zone Requirements - West Coast: ~6-hour overlap with China; flexibility for late afternoon/evening PST collaboration - OR - East Coast: ~6-hour overlap with EU; flexibility for early morning EST collaboration (approx. 5:00–11:00 AM EST)

Job Requirements

  • Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related field
  • 5+ years of SAS programming experience within pharmaceutical/biotech
  • Strong understanding of statistical methods used in clinical trial analysis
  • Knowledge of Good Programming Practices and GCP
  • Preferred: Experience with R programming
  • Strong expertise in CDISC standards, including ADaM and SDTM
  • Demonstrated experience reviewing specs and ensuring high-quality, submission-ready deliverables
  • Experience validating CRO programming deliverables
  • Ability to operate with increased performance accountability and ownership
  • Strong CRO-facing communication and collaboration skills
  • Proven ability to manage multiple global studies simultaneously
  • Time Zone Requirements
  • West Coast: ~6-hour overlap with China; flexibility for late afternoon/evening PST collaboration
  • OR
  • East Coast: ~6-hour overlap with EU; flexibility for early morning EST collaboration (approx. 5:00–11:00 AM EST)

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