SAS programming in the pharmaceutical industry / Jack Shostak.

Format:

Book

Author/Creator:

Shostak, Jack, author.

Contributor:

SAS Institute, Content Provider.

Language:

English

Subjects (All):

SAS (Computer file).

Pharmaceutical technology--Data processing.

Pharmaceutical technology.

Pharmaceutical industry--Data processing.

Pharmaceutical industry.

Physical Description:

1 online resource (308 pages)

Edition:

Second edition.

Place of Publication:

Cary, North Carolina : SAS Institute Inc., [2014]

Language Note:

English

System Details:

text file

Summary:

This comprehensive resource provides on-the-job training for statistical programmers who use SAS in the pharmaceutical industry This one-stop resource offers a complete review of what entry- to intermediate-level statistical programmers need to know in order to help with the analysis and reporting of clinical trial data in the pharmaceutical industry. SAS Programming in the Pharmaceutical Industry, Second Edition begins with an introduction to the pharmaceutical industry and the work environment of a statistical programmer. Then it gives a chronological explanation of what you need to know to do the job. It includes information on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. This edition has been updated for SAS 9.4, and it features new graphics as well as all new examples using CDISC SDTM or ADaM model data structures. Whether you're a novice seeking an introduction to SAS programming in the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, this real-world reference guide offers a wealth of practical suggestions to help you sharpen your skills. This book is part of the SAS Press program.

Contents:

Intro

Additional Resources

Contents

List of Programs

Chapter 1

Chapter 2

Chapter 3

Chapter 4

Chapter 5

Chapter 6

Chapter 8

About This Book

Purpose

Is This Book for You?

Prerequisites

What's New in This Edition

About the Examples

Example Code and Data

Output and Graphics

Keep in Touch

To Contact the Author through SAS Press

SAS Books

SAS Book Report

About The Author

Acknowledgments

Chapter 1 Environment and Guiding Principles

The Statistical Programmer's Working Environment

Pharmaceutical Industry Vocabulary

Statistical Programmer Work Description

The Drug/Device Development Process

Industry Regulations and Standards

Your Clinical Trial Colleagues

Guiding Principles for the Statistical Programmer

Understand the Clinical Study

Program a Task Once and Reuse Your Code Everywhere

Clinical Trial Data Are Dirty

Use SAS Macros Judiciously

A Good Programmer Is a Good Student

Strive to Make Your Programming Readable

Chapter 2 Preparing and Classifying Clinical Trial Data

Preparing Clinical Trial Data

"Clean" the Data If They Are Needed for Analysis

Categorize Data If Necessary

Avoid Hardcoding Data

Classifying Clinical Trial Data

Demographics and Trial-Specific Baseline Data

Concomitant or Prior Medication Data

Medical History Data

Investigational Therapy Drug Log

Laboratory Data

Adverse Event Data

Endpoint/Event Assessment Data

Clinical Endpoint Committee (CEC) Data

Study Termination Data

Treatment Randomization Data

Quality-of-Life Data

Chapter 3 Importing Data

Importing Relational Databases and Clinical Data Management

Systems

SAS/ACCESS SQL Pass-Through Facility

SAS/ACCESS LIBNAME Statement

Importing ASCII Text

PROC IMPORT and the Import Wizard.

SAS DATA Step

SAS Enterprise Guide

Importing Microsoft Office Files

LIBNAME Statement

Import Wizard and PROC IMPORT

Importing XML

XML LIBNAME Engine

SAS XML Mapper

Importing CDISC Model Content Files

Importing CDISC SAS Transport Format Files

Importing define.xml

Importing CDISC ODM Files

Chapter 4 Transforming Data and Creating Analysis Data Sets

Key Concepts for Creating Analysis Data Sets

Defining Variables Once

Defining Study Populations

Defining Baseline Observations

Last Observation Carried Forward (LOCF)

Defining Study Day

Windowing Data

Transposing Data

Categorical Data and Why Zero and Missing Results

Differ Greatly

Performing Many-to-Many Comparisons/Joins

Using Medical Dictionaries

Other Tricks and Traps in Data Manipulation

Common Analysis Data Sets

Subject Level Analysis Data Set

Change-from-Baseline Data Set

Time-to-Event Data Set

Chapter 5 Creating Tables and Listings

Creating Tables

General Approach to Creating Tables

A Typical Clinical Trial Table

Using PROC TABULATE to Create Clinical Trial Tables

Using PROC REPORT to Create Clinical Trial Tables

Creating Typical Continuous/Categorical Summary Tables

Creating Adverse Event Summaries

Creating Concomitant or Prior Medication Tables

Creating a Laboratory Shift Table

Creating Kaplan-Meier Survival Estimates Tables

Creating Listings

Output Appearance Options and Issues

Creating ASCII Text Output

Creating Rich Text Format (RTF) Output

Creating Portable Document Format (PDF) Files

"Page X of N" Pagination Solutions

Footnote Indicating SAS Program and Date

ODS Report Writing Interface

The Power of ODS STYLE

SAS Macro-Based Reporting Systems.

Chapter 6 Creating Clinical Trial Graphs

Common Clinical Trial Graphs

Scatter Plot

Line Plot

Bar Chart

Box Plot

Forest Plot

Kaplan-Meier Survival Estimates Plot

SAS Tools for Creating Clinical Trial Graphs

Sample Graphs

Creating a Scatter Plot

Creating a Line Plot

Creating a Bar Chart

Creating a Box Plot

Creating a Forest Plot

Creating a Kaplan-Meier Survival Estimates Plot

Using SAS Graphics Assistants

Graph-N-Go

ODS Graphics Designer

ODS Graphics Editor

When You Should Use SAS Graphics

Chapter 7 Performing Common Analyses and Obtaining Statistics

Obtaining Descriptive Statistics

Using PROC FREQ to Export Descriptive Statistics

Using PROC UNIVARIATE to Export Descriptive Statistics

Obtaining Inferential Statistics from Categorical Data Analysis

Performing a 2x2 Test for Association

Performing an NxP Test for Association

Performing a Stratified NxP Test for Association

Performing Logistic Regression

Obtaining Inferential Statistics from Continuous Data Analysis

Performing a One-Sample Test of the Mean

Performing a Two-Sample Test of the Means

Performing an N-Sample Test of the Means

Obtaining Time-to-Event Analysis Statistics

Obtaining Correlation Coefficients

General Approach to Obtaining Statistics

Chapter 8 Exporting Data

Exporting Data to the FDA

Using the SAS XPORT Transport Format

Creating ODM XML and define.xml

Exporting Data Not Destined for the FDA

Exporting Data with PROC CPORT

Exporting ASCII Text

Exporting Data to Microsoft Office Files

Exporting Other Proprietary Data Formats

Encryption and File Transport Options

Chapter 9 The Future of SAS Programming in Clinical Trials

Changes in the Business Environment

Changes in Technology

Changes in Regulations.

Changes in Standards

Use of SAS Software in the Clinical Trial Industry

Chapter 10 Further Resources

Regulatory Resources

SAS Programming Validation

FDA Resources

Standards and Industry Organizations

SAS Help

Google Search

lexjansen.com

SAS-L

SAS Technical Support

SAS Users Groups

SAS Manuals and Online Documentation

SAS Press

SAS Focus Areas

Third-Party SAS Web Pages

Useful Technical Skills

Scripting

Version Control Software

VBScript/JavaScript for Applications

Systems Development Methodology

Modeling Tools

Markup Languages

File Transport and Data Encryption Technologies

Other Applications Development Languages

Qualifying for and Obtaining a Job

Glossary

Index.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Description based on print version record.

ISBN:

9781612908052

1612908055

OCLC:

900292103