Senior Clinical Programmer (sdtm) - Homebased

IQVIA

Fully remote
Sdtm dataset creation
Technical specifications and mapping
Backend edit checks and listings
IQVIA is seeking a Senior Clinical Programmer specializing in SDTM for a home-based position. The role entails developing technical specifications, data review models, and electronic submission packages while ensuring compliance with regulatory standards

Job Summary

  • Review and provide input into all trial set-up documentation, translating protocol into detailed technical specifications and mapping documentation.
  • Create Data Review Models (DRM) and SDTM datasets, along with backend edit checks, listings, and visualizations for risk-based central monitoring.
  • Develop and validate electronic submission packages compliant with regulatory agency requirements and support the development of organizational standards.

Matching Summary

Match Score: 85

IQVIA is seeking a Senior Clinical Programmer specializing in SDTM for a home-based position. The role entails developing technical specifications, data review models, and electronic submission packages while ensuring compliance with regulatory standards.

Skills & Requirements

Must-have

  • SDTM dataset creation
  • technical specifications and mapping
  • backend edit checks and listings
  • risk-based central monitoring
  • electronic submission packages
  • SAS, SQL, Python, R programming

Nice-to-have

  • transforming vendor data into SDTM
  • cross-functional team communication
  • organizational and leadership skills

Key Requirements

  • Minimum 4+ years of relevant experience
  • Good knowledge of data structures
  • Strong knowledge of complex finding data types
  • Advanced knowledge of SDTM, Define.xml, CDASH
  • Demonstrated understanding of industry standards

Work Rights

Not specified

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