SAS for Clinical Research & Pharma

Categories: SAS

About Course

SAS for Clinical Research & Pharma is a specialized hands-on course that teaches you how to apply SAS programming in the context of clinical trials and drug development. Learn to manage clinical trial data, generate TLFs (Tables, Listings, and Figures), and work with CDISC standards like SDTM and ADaM. The course includes real-world case studies to help you understand regulatory requirements and produce FDA-ready reports.

Whether you’re entering the pharmaceutical industry or preparing for a role as a Clinical SAS Programmer, this course provides the practical tools and domain knowledge you need to succeed.

Overview of clinical trials, protocols, and regulatory guidelines
Reading and validating clinical trial datasets using SAS
Generating Tables, Listings, and Figures (TLFs) using SAS procedures
Understanding CDISC, SDTM, and ADaM data structures
Creating FDA-compliant analysis datasets
Using macros for automating TLF generation
Writing efficient code for regulatory submissions and audits
Hands-on project simulating a clinical trial report submission

Course Content

Module 1: Introduction to Clinical Research
Clinical trial phases and key terminology Role of SAS in pharma and regulatory submissions

Module 2: Clinical Data Management with SAS
Importing and cleaning raw clinical datasets Generating frequency and descriptive statistics

Module 3: Generating TLFs (Tables, Listings, Figures)
PROC REPORT, PROC TABULATE, PROC TEMPLATE Formatting outputs for clinical review

Module 4: CDISC Standards – SDTM & ADaM
Overview of CDISC compliance SDTM domain mapping using SAS Creating ADaM analysis datasets

Module 5: Automation and Validation
Writing macros for repetitive reporting tasks Validating outputs for audit trails

Module 6: Regulatory-Ready Output
Formatting outputs for FDA submission Real-world case study: Mock FDA package generation

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SAS for Clinical Research & Pharma

About Course

What Will You Learn?

Course Content

Module 1: Introduction to Clinical Research
Clinical trial phases and key terminology Role of SAS in pharma and regulatory submissions

Module 2: Clinical Data Management with SAS
Importing and cleaning raw clinical datasets Generating frequency and descriptive statistics

Module 3: Generating TLFs (Tables, Listings, Figures)
PROC REPORT, PROC TABULATE, PROC TEMPLATE Formatting outputs for clinical review

Module 4: CDISC Standards – SDTM & ADaM
Overview of CDISC compliance SDTM domain mapping using SAS Creating ADaM analysis datasets

Module 5: Automation and Validation
Writing macros for repetitive reporting tasks Validating outputs for audit trails

Module 6: Regulatory-Ready Output
Formatting outputs for FDA submission Real-world case study: Mock FDA package generation

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About Course

What Will You Learn?

Course Content

Module 1: Introduction to Clinical Research Clinical trial phases and key terminology Role of SAS in pharma and regulatory submissions

Module 2: Clinical Data Management with SAS Importing and cleaning raw clinical datasets Generating frequency and descriptive statistics

Module 3: Generating TLFs (Tables, Listings, Figures) PROC REPORT, PROC TABULATE, PROC TEMPLATE Formatting outputs for clinical review

Module 4: CDISC Standards – SDTM & ADaM Overview of CDISC compliance SDTM domain mapping using SAS Creating ADaM analysis datasets

Module 5: Automation and Validation Writing macros for repetitive reporting tasks Validating outputs for audit trails

Module 6: Regulatory-Ready Output Formatting outputs for FDA submission Real-world case study: Mock FDA package generation

Student Ratings & Reviews

Trending Courses

Trending College Workshops

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Categories

Module 1: Introduction to Clinical Research
Clinical trial phases and key terminology Role of SAS in pharma and regulatory submissions

Module 2: Clinical Data Management with SAS
Importing and cleaning raw clinical datasets Generating frequency and descriptive statistics

Module 3: Generating TLFs (Tables, Listings, Figures)
PROC REPORT, PROC TABULATE, PROC TEMPLATE Formatting outputs for clinical review

Module 4: CDISC Standards – SDTM & ADaM
Overview of CDISC compliance SDTM domain mapping using SAS Creating ADaM analysis datasets

Module 5: Automation and Validation
Writing macros for repetitive reporting tasks Validating outputs for audit trails

Module 6: Regulatory-Ready Output
Formatting outputs for FDA submission Real-world case study: Mock FDA package generation