This book was written for the entry- to intermediate-level SAS programmer who helps with the analysis and reporting of clinical trial data in the pharmaceutical industry. The industry may call this individual a “SAS programmer,” “clinical SAS programmer,” “statistical/stats programmer,” “programmer/analyst,” or any of a host of other names. In this book we call this individual a statistical programmer. Although this book may prove useful to clinical trial statisticians, it is aimed more at the statistical programmer who assists the lead trial statistician in producing the large amount of reporting required. This book assumes that the reader has no prior knowledge of clinical trials and some knowledge of SAS programming.

Most statistical programmers who end up working in clinical trial analysis happen upon the field by accident. This is primarily because historically there have been few if any formal training programs for clinical trial SAS programming. As a result, most statistical programmers have to learn about clinical trial analysis and reporting on the job. I thought it would be beneficial to have a resource for the junior statistical programmer that brings together in one volume much of the knowledge required to do clinical trial reporting. This book is organized chronologically according to the statistical programmer’s workflow. There is an introductory chapter that defines the working environment and sets the basic ground rules for the job. Then, there are chapters on importing data and massaging data into analysis data sets. Producing clinical trial report output is covered in the chapters on tables, listings, and graphs. Finally, there is a chapter on exporting data, followed by a discussion of the future for statistical programmers and a closing chapter on further resources.

The examples in this book focus primarily on the tools within SAS/GRAPH, SAS/STAT, and Base SAS, including the SAS macro language and PROC SQL. The examples were developed using SAS 9.1.3, but the vast majority of the examples will run with other versions of SAS as well. Please note that the data that drive the examples in this book are obtained through INPUT statements with DATALINES data. This is done only for illustrative purposes and does not mean that you should expect to obtain your clinical data in this fashion.