Programmer in Clinical Trials

Our approach to teaching will be a collaborative hands-on work with end-to-end dummy clinical data. You will gain necessary skills to create specifications, produce and validate datasets as well as produce simple and complex tables, listings and figures.

Week 1 Week 2, 3 Week 4 Week 5
  • Introductions
  • Clinical Trials SDTM specifications
  • SDTM assignments
  • Create source and validation for SDTM
  • SDRG
  • Dictionaries
  • Define.xml for SDTM
  • ADaM specifications
Week 6, 7 Week 8 Week 9,  10,  11 Week 12
  • ADaM assignments
  • Create source and validation for ADaM
  • ADRG
  • Define.xml for ADaM
  • Tables
  • Listings
  • Figures
  • Presentation
  • End of Training
Acronyms:
SDTM = Standard Data Tabulation Model
ADaM = Analysis Data Model
SDRG = Study Data Reviewer’s Guide
ADRG = Analysis Data Reviewer’s Guide

  • BS. in Bioinformatics, Biotechnology, Biostatistics, Data Science or any analytical background.
  • Minimum knowledge about SAS or R programming and willingness to put effort into learning new skills.

TRAINER

IULIANA CONSTANTIN
IULIANA CONSTANTINFounder
Iuliana Constantin has over 15 years of extensive SAS programming experience in solving non-routine situations in the pharmaceutical, diagnostic and device industry. She is passionate about sharing her knowledge gained in the industry with the new generation of leaders in the industry.

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