Clinical SAS

The curriculum is carefully structured by experienced industry professionals and aligned with FDA submission requirements and global regulatory standards followed by CROs, pharmaceutical companies, and sponsors worldwide. The program emphasizes accuracy, compliance, and best practices required to ensure data integrity and regulatory readiness in clinical trials.

This specialized Clinical SAS Training Program focuses on building the practical skills required to manage, analyze, and submit standardized clinical trial data. You will gain hands-on experience in clinical programming, data validation, and regulatory reporting, using real-world clinical trial scenarios—preparing you for entry-level and intermediate Clinical SAS roles in the global clinical research industry. What You Will Learn in BCRI’s Clinical SAS Course

Clinical SAS Course online – consists of SAS/Base, SAS/Macros, SAS/ SQL, SAS/Stat, SAS/Access, Clinical Data Interchange Standards Consortium (CDISC), SDTM (Study Data Tabulation Model), ADaM (Analysis Dataset Model), for 3 months.  📘 Introduction to Clinical SAS

  • Overview of SAS in Pharma & CROs
  • CDISC, FDA, EMA & global regulatory context
  • SAS programming environment & basics

📊 SDTM – Study Data Tabulation Model

  • Creating SDTM datasets from raw data
  • Define.XML, Pinnacle 21 validation
  • Domain structure and regulatory submission

📈 ADaM – Analysis Data Model

  • ADSL, BDS, OCCDS datasets & derivations
  • ADaM metadata & define.XML generation
  • Compliance & validation for FDA submission

📑 TLFs – Tables, Listings, Figures

  • Generating summary tables & listings
  • Creating statistical graphs and charts
  • Using PROC REPORT, PROC TABULATE, PROC SGPLOT

📝 Assignments & Hands-On Practice

  • Practice building SDTM and ADaM datasets using real clinical data
  • Generate mock TLFs for protocol-specified endpoints
  • Assignment-based review of Define.XML, Pinnacle 21, and regulatory formats

🔧 SAS Macros, SQL & Debugging

  • Automation using Macros & Macro variables
  • SQL joins, data extraction & report queries
  • System options & troubleshooting techniques

Skills You Gain with Clinical SAS Training

By completing BCRI’s Clinical SAS Training Program, you’ll develop the technical, analytical, and regulatory skills needed to work confidently in clinical data programming and biostatistics roles across the global pharma industry.

✅ Key Skills You’ll Develop:

  • Proficiency in Base SAS Programming (DATA step, PROC step, functions, arrays, loops, and debugging)
  • SAS Macros & SQL for Data Manipulation and automation of reports
  • Knowledge of CDISC Standards including SDTM & ADaM structure and compliance
  • Hands-on experience with TLFs/TLGs – Tables, Listings, and Figures for statistical reporting
  • Understanding of Clinical Trial Data Lifecycle from raw data to submission-ready datasets
  • Ability to clean, merge, and validate datasets used in Phase I–IV clinical studies
  • FDA/EMA Submission Readiness – work with mock 120-day packages and standard datasets
  • Real-time coding on SAS 9.4 environment with sample clinical datasets