Course Overview

Clinical SAS is the application of SAS software in pharmaceutical, biotechnology, healthcare and clinical research industries for managing, analyzing and reporting clinical trial data.

Course Modules

Module 1: Introduction to Clinical SAS

Introduction to SAS
Role of SAS in Clinical Research
Drug Development Process Overview
Clinical Trial Lifecycle
Clinical SAS Industry Overview
Clinical SAS Career Opportunities
SAS Environment and Navigation

Module 2: SAS Fundamentals

SAS Architecture
SAS Windows and Interface
Libraries and Datasets
SAS Data Types
Variables and Attributes
Permanent and Temporary Datasets
Importing and Exporting Data

Module 3: SAS Programming Basics

DATA Step Processing
SET Statement
INPUT Statement
INFILE Statement
Assignment Statements
Conditional Statements
IF-THEN-ELSE Logic
DO Loops
Arrays Introduction

Module 4: SAS Functions

Character Functions
Numeric Functions
Date Functions
String Manipulation Functions
Missing Value Handling
Data Conversion Functions
Mathematical Functions

Module 5: Data Manipulation

Dataset Creation
Dataset Merging
Concatenation
Interleaving
Splitting Datasets
Sorting Data
Removing Duplicates
Data Cleaning Techniques

Module 6: PROC Procedures

PROC PRINT
PROC SORT
PROC CONTENTS
PROC FORMAT
PROC FREQ
PROC MEANS
PROC REPORT
PROC TABULATE
PROC UNIVARIATE
PROC TTEST
PROC ANOVA
PROC REG
PROC CORR

Module 7: Advanced SAS Programming

Macro Programming Basics
Macro Variables
Macro Functions
User-Defined Macros
Dynamic Programming
Reusable Programs
Performance Optimization

Module 8: Clinical Trial Data Fundamentals

Clinical Trial Phases
Study Design Basics
Protocol Overview
CRFs
eCRFs
Clinical Data Flow
Clinical Databases

Module 9: CDISC Standards

Introduction to SDTM
SDTM Domains
SDTM Structure
SDTM Mapping Concepts
SDTM Dataset Creation
Introduction to ADaM
Analysis Dataset Creation
ADaM Standards
Traceability Concepts
Introduction to CDASH
Data Collection Standards

Module 10: Clinical Reporting

Tables Listings and Figures
Clinical Summary Tables
Demographic Reports
Adverse Event Reports
Laboratory Reports
Patient Listings
Regulatory Reporting Requirements

Module 11: Data Validation & Quality Control

Programming Validation
Double Programming Concepts
Quality Control
Data Verification
Error Identification
Documentation Standards

Module 12: Statistical Concepts for Clinical SAS

Descriptive Statistics
Inferential Statistics
Hypothesis Testing
Confidence Intervals
P-Values
Randomization Concepts
Survival Analysis Basics

Module 13: Regulatory Requirements

FDA Submission Standards
EMA Submission Standards
CDISC Compliance
Good Clinical Practice
21 CFR Part 11
Regulatory Documentation

Module 14: Clinical SAS Project Workflow

Project Setup
Requirement Analysis
Programming Specifications
Dataset Development
Report Generation
Quality Review
Final Deliverables

Module 15: Real-Time Clinical SAS Projects

SDTM Mapping Project
ADaM Dataset Creation
Demographic Table Generation
Adverse Event Reporting Project
Laboratory Data Analysis
TLF Development Project
End-to-End Clinical Study Reporting

Module 16: Clinical SAS Career Development

Clinical SAS Programmer
Statistical Programmer
SAS Analyst
Biostatistics Programmer
Lead Programmer
Project Lead
Career Growth Pathways

Practical Training

✅ SAS Installation and Setup

✅ Writing SAS Programs

✅ Dataset Creation Exercises

✅ Data Manipulation Practice

✅ PROC Procedures Hands-On

✅ Macro Programming Exercises

✅ SDTM Mapping Exercises

✅ ADaM Dataset Development

✅ TLF Generation Practice

✅ Clinical Study Case Studies

Interview Preparation

🎯 Clinical SAS Interview Questions

🎯 SAS Programming Assessments

🎯 HR Interview Preparation

🎯 Resume Building Guidance

🎯 LinkedIn Profile Optimization

🎯 Professional Communication Skills

🎯 Corporate Etiquette

What You'll Achieve

Gain comprehensive understanding of SAS programming, SDTM, ADaM, CDISC standards, data analysis, statistical reporting, regulatory requirements and clinical study reporting.