Video description
The course takes you through an example clinical study sample data and generates various clinical study reports that are submitted to the FDA (in the US) or other regulatory authorities in other countries. You will not only hone your SAS programming skills but will also learn essential concepts needed to work in the pharma industry in the areas of biostatistics and clinical data management.
After the introduction to the pharma industry and learning relevant concepts about clinical trials, the course takes you through a hands-on training exercise to build the very important and fundamental clinical study report, called the demographics table.
You will begin with a sample clinical study data in an Excel sheet, then you will import it into SAS, derive all necessary variables as shown in the mock table, and finally, generate a clinical study report. All this will be done using guided SAS programming steps with detailed explanations at every step of the programming.
By the end of this course, you will have learned to work with clinical study data, generate a real clinical study report, and extend those steps to build other reports that constitute clinical trial submissions to the regulatory bodies.
What You Will Learn
- Learn the fundamental concepts of clinical drug development/trials
- Understand various phases of clinical trials in the context of SAS programming
- Get introduced to the usage of various clinical study documents
- Collect, store, analyze, and report data using SAS
- Collect, store, analyze, and report data using SAS
- Generate clinical study reports from the derived data you will create
Audience
Anyone who wants to take up a job as a clinical SAS programmer in a pharma company will find this course useful. Individuals who want to just play with data using the SAS programming concepts and want to take up a job as a clinical SAS programmer in a pharma company or a CRO will also benefit from this course.
Please note that basic SAS programming is a requirement to complete this course. No prior pharmaceutical experience is necessary. Internet connectivity is necessary for working in the SAS Studio Edition using SAS OnDemand (no installation required).
About The Author
Aslam Khan: Aslam Khan works with businesses in understanding their complex problems, surfacing their business needs and offering viable technical solutions, overseeing change management, program benefits realization, and organizational project management. He has also worked in the clinical data management, biostatistics, and SAS programming areas of the life sciences industry.
He is a certified Project Management Professional (PMP) and a SAS Base and Advanced Certified Programmer, with a master’s degree in management information systems.
Table of contents
- Chapter 1 : Introduction
- Chapter 2 : Get to Know the Clinical Study Documents
-
Chapter 3 : Building the Clinical Study Reports (CSR)
- Section Overview
- SAS OnDemand Registration
- Logging-In to SAS After Registration
- General SAS Programming Steps to Build Any CSRs
- Understanding the Demographics Case Report Form (CRF)
- Understanding the Demographics Table
- Planning to Program the Demographics Table
- Importing Raw Demographics Data into SAS
- Deciding Which PROCs to Use
- Deriving the AGE Variable
- Obtaining Summary Statistics for AGE
- Adding the Third Treatment Group Using Explicit Output
- Deriving the SEX Variable
- Obtaining Summary Statistics for SEX
- Concatenating the COUNT and PERCENT Variables
- Deriving the RACE Variable
- Obtaining Summary Statistics for RACE
- Stacking All Three Summary Statistics Together
- Fixing the Precision Points
- Transposing Data
- Fixing the Order of Statistical Parameters
- Building the Final Report
- Putting the Finishing Touches to the Report
- Section Conclusion
Product information
- Title: The Simplest Guide™ to Clinical Data Analysis with SAS
- Author(s):
- Release date: February 2021
- Publisher(s): Packt Publishing
- ISBN: 9781801077095
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