Senior Clinical Programmer (sdtm) - Homebased

IQVIA

Multiple Locations
Sdtm dataset creation
Backend edit checks and listings
Risk-based central monitoring
Review and provide input into all trial set-up documentation, translating protocols into detailed technical specifications and mapping documentation

Job Summary

  • Review and provide input into all trial set-up documentation, translating protocols into detailed technical specifications and mapping documentation.
  • Create SDTM datasets, backend edit checks, listings, and visualizations to support risk-based central monitoring and data review.
  • Develop and validate electronic submission packages compliant with regulatory agency requirements.

Matching Summary

Review and provide input into all trial set-up documentation, translating protocols into detailed technical specifications and mapping documentation.

Skills & Requirements

Must-have

  • SDTM dataset creation
  • 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
  • organizational and leadership skills
  • cross-functional team communication

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

Tailored Resume

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