The Simplest Guide™ to Clinical Data Analysis with SAS

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. The code files and all related files are added on GitHub at https://github.com/PacktPublishing/The-Simplest-Guide-to-Clinical-Data-Analysis-with-SAS-

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
Import, prepare, restructure, and visualize data
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).

Approach

This course explains concepts in an easy-to-understand manner by illustrating each concept in great detail. This course uses the method of learning and practice in an effective way to achieve the goal of the course.

Key Features

Dive head-first into the life sciences/pharmaceutical industry * Master concepts of clinical drug development/clinical trials processes * Learn how SAS programming is an integral part of putting a drug into the market

Github Repo

https://github.com/PacktPublishing/The-Simplest-Guide-to-Clinical-Data-Analysis-with-SAS-

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.

Course Outline

1. Introduction

2. Get to Know the Clinical Study Documents

3. Building the Clinical Study Reports (CSR)