Job Description
Data Standards & Harmonization
 • Lead end-to-end mapping and transformation of SDTM domains
 • Ensure compliance with:
  ○ CDISC SDTM standards
  ○ Sponsor-specific controlled terminology and structure
 • Perform consistency checks against previously harmonized datasets
 • Support harmonized datasets for integrated analysis readiness

ADaM Dataset Creation
 • Develop ADaM datasets (using Admiral R package) based on:
  ○ Statistical Analysis Plan (SAP)
  ○ Analysis specifications
 • Ensure traceability between SDTM and ADaM
 • Implement:
  ○ Derived variables
  ○ Population flags
  ○ Analysis endpoints

Regulatory-Ready Documentation & Deliverables
Prepare submission-ready outputs aligned with FDA/EMA expectations, including:
 • SDTM & ADaM datasets (with define.xml)
 • Dataset-level and analysis-level documentation
 • Example outputs and sample displays
 • Integrated Case Report Forms (iCRFs)