What you'll learn
By the end of this course, you’ll be able to manage, analyze, and validate clinical trial data, prepare submission-ready datasets and reports, and work confidently in CROs or pharma companies.
Core topics
- SAS Programming Basics
- Data Manipulation & Reporting
- Clinical Data Standards (CDISC, SDTM, ADaM)
- Clinical Trial Data Analysis
- Macros, Functions & Automation
Hands-on
- Case studies using clinical trial datasets
- Generating TLFs (Tables, Listings, Figures)
- Building ADaM datasets
- End-to-end clinical reporting project
- Capstone: Submission-ready SAS package
Course syllabus
01
Introduction to SAS
Basics of SAS, Environment, and Syntax
+
Topics: SAS interface, libraries, datasets, syntax rules, and import/export
operations.
02
Data Handling & Manipulation
DATA step, functions & operators
+
Topics: Conditional statements, loops, merging, concatenation, and arrays.
03
Procedures & Reporting
PROC MEANS, FREQ, REPORT, TABULATE
+
Topics: Generating summary tables, listings, and descriptive statistics reports.
04
Clinical Domain Programming
Introduction to CDISC, SDTM, ADaM
+
Topics: Data mapping, standardization, creation of clinical domains.
05
Statistical Analysis & Validation
TLFs, data derivations, and validation checks
+
Topics: Creating tables, listings, and figures; QC and double programming.
06
Advanced SAS Techniques
Macros, functions, automation
+
Topics: Macro variables, loops, automation of reports, debugging.
07
End-to-End Project
Clinical trial dataset to final report
+
Topics: Preparing SDTM datasets, generating ADaM, producing outputs, submission-ready
reports.
Projects & Capstone
Hands-on projects designed to simulate real pharmaceutical data analysis workflows.
- Demographics & Adverse Events Reporting
- Laboratory Data Summarization
- Exposure Analysis using SAS Macros
- Subject Disposition Dataset
- QC of SDTM & ADaM Datasets
- Capstone: End-to-End Clinical Trial Reporting
Instructor
SN
Shreya Nair
Clinical SAS Programmer — 8+ years experience
Office hours: Tue & Fri 6–8 PM
Frequently Asked Questions
Is this course suitable for beginners?
Yes, it starts from the basics and gradually builds to advanced clinical programming
concepts.
Will I get a certificate?
Yes, upon completion of all modules and the final capstone project.
Do I need pharma background?
No, basic understanding of data and healthcare is sufficient — everything else is covered.