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.
For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have updated their popular Implementing CDISC Using SAS, the first comprehensive book on applying clinical research data and metadata to the Clinical Data Interchange Standards Consortium (CDISC) standards. Implementing CDISC Using SAS: An End-to-End Guide, Second Edition, is an all-inclusive guide on how to implement and analyze the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submission. Updated to reflect the 2017 FDA mandate for adherence to CDISC standards, this new edition covers creating and using metadata, developing conversion specifications, implementing and validating SDTM and ADaM data, determining solutions for legacy data conversions, and preparing data for regulatory submission. The book covers products such as Base SAS, SAS Clinical Data Integration, and the SAS Clinical Standards Toolkit, as well as JMP Clinical. Topics included in this new edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, and of course new versions of SAS and JMP software. Any manager or user of clinical trial data in this day and age is likely to benefit from knowing how to either put data into a CDISC standard or analyzing and finding data once it is in a CDISC format. If you are one such person--a data manager, clinical and/or statistical programmer, biostatistician, or even a clinician--then this book is for you.
Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.
This clear and comprehensive guide provides everything you need for powerful linear model analysis. Using a tutorial approach and plenty of examples, authors Ramon Littell, Walter Stroup, and Rudolf Freund lead you through methods related to analysis of variance with fixed and random effects. You will learn to use the appropriate SAS procedure for most experiment designs (including completely random, randomized blocks, and split plot) as well as factorial treatment designs and repeated measures. SAS for Linear Models, Fourth Edition, also includes analysis of covariance, multivariate linear models, and generalized linear models for non-normal data. Find inside: regression models; balanced ANOVA with both fixed- and random-effects models; unbalanced data with both fixed- and random-effects models; covariance models; generalized linear models; multivariate models; and repeated measures. New in this edition: MIXED and GENMOD procedures, updated examples, new software-related features, and other new material. This book is part of the SAS Press program.
Why does SAS use January 1, 1960 as its arbitrary reference date? How do you convert a value such as 27 January 2003 into a SAS date? How do you put a date into a filename, or label an Excel worksheet with the date? You'll find the answers to these questions and much more in Derek Morgan's Essential Guide to SAS Dates and Times, Second Edition, which makes it easy to understand how to use and manipulate dates, times, and datetimes in SAS. Updated for SAS 9.4, with additional functions, formats, and capabilities, the Second Edition has a new chapter dedicated to the ISO 8601 standard and the formats and functions that are new to SAS, including how SAS works with Universal Coordinated Time (UTC). Novice users will appreciate the new "Troubleshooting" appendix, which discusses questions common to newer SAS users in a conversational way and provides clear examples of simple solutions to these questions. Both novice and intermediate users will find the clear, task-based examples on how to accomplish date-related tasks and the detailed explanations of standard formats and functions invaluable. Users working with intervals will appreciate the expanded discussion of the topic, which details the new custom interval capability, among other enhancements to intervals. Users working with international dates and times will benefit from the detailed discussion of the NLS facility as it relates to dates and times. Included are bonus "Quick Reference Guides" that list both the standard date and time formats and the NLS date and time formats with examples. These guides illustrate how each format displays the same date, time, or datetime, so you can find the format you want to use at a glance. The Essential Guide to SAS Dates and Times, Second Edition is the most complete and up-to-date collection of examples on how to write complex programs involving dates, times, or datetime values. This book is part of the SAS Press Program.
Thoroughly updated edition of the popular introductory statistics book for clinical researchers. This new edition has been extensively updated to include the use of ODS graphics in numerous examples as well as a new emphasis on PROC MIXED.
Bridging the gap between statistics texts and SAS documentation, Elementary Statistics Using SAS is written for those who want to perform analyses to solve problems. The first section of the book explains the basics of SAS data sets and shows how to use SAS for descriptive statistics and graphs. The second section discusses fundamental statistical concepts, including normality and hypothesis testing. The remaining sections of the book show analyses for comparing two groups, comparing multiple groups, fitting regression equations, and exploring contingency tables. For each analysis, author Sandra Schlotzhauer explains assumptions, statistical approach, and SAS methods and syntax, and makes conclusions from the results. Statistical methods covered include two-sample t-tests, paired-difference t-tests, analysis of variance, multiple comparison techniques, regression, regression diagnostics, and chi-square tests. Elementary Statistics Using SAS is a thoroughly revised and updated edition of Ramon Littell and Sandra Schlotzhauer's SAS System for Elementary Statistical Analysis. This book is part of the SAS Press program.
An Illustrated Step-by-Step Guide for New Users, Second Edition
Author: Curt Hinrichs
Publisher: SAS Institute
Grasp essential steps in order to generate meaningful results quickly with JMP. JMP Essentials: An Illustrated Step-by-Step Guide for New Users, Second Edition is designed for the new or occasional JMP user who needs to generate meaningful graphs or results quickly. Drawing on their own experience working with these customers, the authors provide essential steps for what new users typically need to carry out with JMP. This newest edition has all new instructions and screen shots reflecting the latest release of JMP software. In addition, it has eight new detailed sections and 10 new subsections that include creating maps, filtering data, creating dashboards, and working with Excel data, all of which highlight new, useful and basic level enhancements to JMP. The format of the book is unique. It adopts a show-and-tell design with essential step-by-step instructions and corresponding screen illustrations, which help users quickly see how to generate the desired results. In most cases, each section completes a JMP task, which maximizes the book's utility as a reference. In addition, each chapter contains a family of features that are carefully crafted to first introduce you to basic features and then on to more advanced ones. JMP Essentials: An Illustrated Step-by-Step Guide for New Users, Second Edition is the quickest and most accessible reference book available. This is part of the SAS Press program.
This updated edition shows how to use SAS to perform basic statistical analysis. General topics include creating a data set with SAS; summarizing data with descriptive statistics, frequency tables, and bar charts; comparing groups (t-tests, one-way ANOVA, and nonparametric analogues); performing basic linear regression (lines, curves, and two-variable models); performing simple regression diagnostics (residuals plots, studentized residuals); and creating and analyzing tables of data. Using real-life examples, this beginner's guide bridges the gap between statistics texts and SAS documentation.
Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology explores statistics used in day-to-day clinical pharmacology work. The book covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the proposed methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, and dose-proportionality trials. Purposefully designed to be instantly applicable, the book provides examples of SAS code so that the analysis described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS. Each chapter includes a vignette based on co-author Scott Patterson's experience in the clinical pharmacology work place and all the data sets are taken from real trials. The authors delineate practical utility and objectives, provide real-world examples of the topic under discussion, and include statistical theory and applications. Technical theory, where extensive, is included in technical appendices at the end of the chapter. Each topic contains worked examples that illustrate the applications of the statistical techniques and their interpretation. The authors also develop statistical tools useful for other topics of clinical pharmacology - namely general safety testing, testing for proarrythmic potential, population pharmacokinetics, and dose-selection.