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*名称：

SAS Programming in the Pharmaceutical Industry (Paperback)
by Jack Shostak (Author)

Paperback: 360 pages
Publisher: SAS Publishing (September 2005)
Language: English
ISBN-10: 1590477936
ISBN-13: 978-1590477939
http://www.amazon.com/Programming-Pharmaceutical-Industry-Jack-Shostak/dp/1590477936/ref=pd_bbs_sr_1/104-5895980-6364743?ie=UTF8&s=books&qid=1178389430&sr=8-1

*大小：352页，7.75M

*格式：PDF

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*目录

Contents
List of Programs xi
Preface xv
Acknowledgments xvii
Chapter 1 Environment and Guiding Principles 1
The Statistical Programmer’s Working Environment 2
Pharmaceutical Industry Vocabulary 2
Statistical Programmer Work Description 2
The Drug/Device Development Process 3
Industry Regulations and Standards 4
Your Clinical Trial Colleagues 8
Guiding Principles for the Statistical Programmer 10
Understand the Clinical Study 11
Program a Task Once and Reuse Your Code Everywhere 12
Clinical Trial Data Are Dirty 13
Use SAS Macros Judiciously 16
A Good Programmer Is a Good Student 18
Strive to Make Your Programming Readable 18
Chapter 2 Preparing and Classifying Clinical
Trial Data 19
Preparing Clinical Trial Data 20
“Clean” the Data If They Are Needed for Analysis 20
Categorize Data If Necessary 21
Avoid Hardcoding Data 24
iv Contents
Classifying Clinical Trial Data 26
Demographics and Trial-Specific Baseline Data 27
Concomitant or Prior Medication Data 27
Medical History Data 29
Investigational Therapy Drug Log 30
Laboratory Data 31
Adverse Event Data 32
Endpoint/Event Assessment Data 35
Clinical Endpoint Committee (CEC) Data 36
Study Termination Data 37
Treatment Randomization Data 38
Quality-of-Life Data 40
Chapter 3 Importing Data 41
Importing Relational Databases and Clinical Data
Management Systems 42
SAS/ACCESS SQL Pass-Through Facility 42
SAS/ACCESS LIBNAME Statement 43
Importing ASCII Text 44
PROC IMPORT and the Import Wizard 44
SAS DATA Step 52
SAS Enterprise Guide 53
Importing Microsoft Office Files 56
LIBNAME Statement 58
Import Wizard and PROC IMPORT 59
SAS/ACCESS SQL Pass-Through Facility 64
SAS Enterprise Guide 65
Importing XML 68
XML LIBNAME Engine 69
SAS XML Mapper 72
PROC CDISC 74
Importing Files in Other Proprietary Data Formats 79
Contents v
Chapter 4 Transforming Data and Creating Analysis
Data Sets 83
Key Concepts for Creating Analysis Data Sets 84
Defining Variables Once 84
Defining Study Populations 85
Defining Baseline Observations 85
Last Observation Carried Forward (LOCF) 86
Defining Study Day 89
Windowing Data 91
Transposing Data 94
Categorical Data and Why Zero and Missing Results
Differ Greatly 102
Performing Many-to-Many Comparisons/Joins 106
Using Medical Dictionaries 108
Other Tricks and Traps in Data Manipulation 112
Common Analysis Data Sets 118
Critical Variables Data Set 118
Change-from-Baseline Data Set 118
Time-to-Event Data Set 121
Chapter 5 Creating Tables and Listings 125
Creating Tables 126
General Approach to Creating Tables 126
A Typical Clinical Trial Table 127
Using PROC TABULATE to Create Clinical Trial Tables 128
Using PROC REPORT to Create Clinical Trial Tables 132
Creating Continuous/Categorical Summary Tables 137
Creating Adverse Event Summaries 146
Creating Concomitant or Prior Medication Tables 162
Creating a Laboratory Shift Table 169
Creating Kaplan-Meier Survival Estimates Tables 176
Creating Listings 184
vi Contents
Output Appearance Options and Issues 191
Creating ASCII Text Output 191
Creating Rich Text Format (RTF) Output 192
Creating Portable Document Format (PDF) Files 194
“Page X of N” Pagination Solutions 196
Footnote Indicating SAS Program and Date 197
SAS Macro-Based Reporting Systems 198
Chapter 6 Creating Clinical Trial Graphs 199
Common Clinical Trial Graphs 200
Scatter Plot 200
Line Plot 201
Bar Chart 202
Box Plot 203
Odds Ratio Plot 203
Kaplan-Meier Survival Estimates Plot 204
SAS Tools for Creating Clinical Trial Graphs 205
Common Clinical Trial SAS/GRAPH Procedures 205
Using the Annotate Facility for Graph Augmentation 206
Sample Graphs 207
Creating a Scatter Plot 207
Creating a Line Plot 210
Creating a Bar Chart 214
Creating a Box Plot 218
Creating an Odds Ratio Plot 228
Creating a Kaplan-Meier Survival Estimates Plot 233
Output Options 240
Selecting Graphics Drivers 240
Using ODS Destinations for SAS/GRAPH 241
Contents vii
Using SAS/GRAPH Assistants 244
Graph-N-Go 245
SAS Enterprise Guide 245
ODS Graphics 245
When You Should Use SAS/GRAPH 246
Chapter 7 Performing Common Analyses and Obtaining
Statistics 247
Obtaining Descriptive Statistics 248
Using PROC FREQ to Export Descriptive Statistics 248
Using PROC UNIVARIATE to Export Descriptive Statistics 249
Obtaining Inferential Statistics from Categorical Data
Analysis 251
Performing a 2x2 Test for Association 251
Performing an NxP Test for Association 252
Performing a Stratified NxP Test for Association 253
Performing Logistic Regression 254
Obtaining Inferential Statistics from Continuous Data
Analysis 255
Performing a One-Sample Test of the Mean 255
Performing a Two-Sample Test of the Means 257
Performing an N-Sample Test of the Means 258
Obtaining Time-to-Event Analysis Statistics 259
Obtaining Correlation Coefficients 260
General Approach to Obtaining Statistics 260
Chapter 8 Exporting Data 263
Exporting Data to the FDA 264
Using the SAS XPORT Transport Format 264
Creating XML Files 266
Exporting Data Not Destined for the FDA 276
Exporting Data with PROC CPORT 276
Exporting ASCII Text 276
viii Contents
Exporting Data to Microsoft Office Files 283
Exporting Other Proprietary Data Formats 287
Encryption and File Transport Options 288
Chapter 9 The Future of SAS Programming in
Clinical Trials 289
Changes in the Business Environment 290
Changes in Technology 290
Changes in Regulations 291
Changes in Standards 291
Use of SAS Software in the Clinical Trial Industry 292
Chapter 10 Further Resources 293
Regulatory Resources 294
SAS Programming Validation 294
FDA Resources 295
Standards and Industry Organizations 296
SAS Help 296
SAS-L 296
SAS Technical Support 297
SAS Users Groups 297
SAS Manuals and Online Documentation 297
SAS Press 298
Community Pages at SAS 298
Third-Party SAS Web Pages 298
Useful Technical Skills 299
Scripting 299
Version Control Software 299
VBScript/JavaScript for Applications 299
Systems Development Life Cycle 299
Modeling Tools 300
Markup Languages 300
Contents ix
File Transport and Data Encryption Technologies 300
Other Applications Development Languages 300
Qualifying for and Obtaining a Job 301
Glossary 303
Index 321

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