SAS Programming in the Pharmaceutical Industry Second Edition

Author: Jack Shostak
Publisher: SAS Institute
ISBN: 9781629591490
Release Date: 2014-03-01
Genre: Mathematics

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.

SAS Programming in the Pharmaceutical Industry

Author: Jack Shostak
Publisher: Sas Inst
ISBN: 1590477936
Release Date: 2005
Genre: Business & Economics

This real-world reference for clinical trial SAS programming is packed with solutions that can be applied day-to-day problems. Organized to reflect the statistical programmers workflow, this user-friendly text begins with an introduction to the working environment, then presents chapters on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data.

Implementing CDISC Using SAS

Author: Chris Holland
Publisher: SAS Institute
ISBN: 9781629605364
Release Date: 2016-11-28
Genre: Computers

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.

Validating Clinical Trial Data Reporting with SAS

Author: Carol I. Matthews
Publisher: SAS Institute
ISBN: 9781599941288
Release Date: 2008
Genre: Computers

This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration.

Pharmaceutical Statistics Using SAS

Author: Alex Dmitrienko
Publisher: SAS Institute
ISBN: 9781599943572
Release Date: 2007
Genre: Computers

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.

Common Statistical Methods for Clinical Research with SAS Examples

Author: Glenn A. Walker
Publisher: SAS Institute
ISBN: 9781607644255
Release Date: 2010-02
Genre: Computers

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.

Analysis of Clinical Trials Using SAS

Author: Alex Dmitrienko
Publisher: SAS Institute
ISBN: 9781635261448
Release Date: 2017-07-17
Genre: Computers

Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.

Clinical Trials

Author: Duolao Wang
Publisher: Remedica
ISBN: 9781901346725
Release Date: 2006
Genre: Medical

This book aims to demystify clinical trials. It is divided into five sections: fundamentals of trial design, alternative trial designs, basics of statistical analysis, special trial issues in data analysis, and reporting of trials. Using simple language the book explains with illustrations of numerous trial examples, the conceptual and methodological issues that occur at all stages of clinical trial covering trial design, conduct, analysis and reporting. The book is an educational and approachable reference in a difficult area of medicine where clinicians often feel uncertain and this material helps them review, appraise and publish trials and clinical evidence.

SAS Hash Object Programming Made Easy

Author: Michele M. Burlew
Publisher: SAS Institute
ISBN: 9781612900988
Release Date: 2012-09-14
Genre: Mathematics

Hash objects, an efficient look-up tool in the SAS DATA step, are object-oriented programming structures that function differently from traditional SAS language statements. Michele Burlew's SAS Hash Object Programming Made Easy shows readers how to use these powerful features, which they can program to quickly look up and manage data and to conserve computing resources. SAS provides various look-up techniques, and hash objects are among the newest, so therefore many users may not have yet used them. Because the examples presented vary in complexity, SAS Hash Object Programming Made Easy is useful to SAS users of all experience levels, from novice programmer to advanced programmer. Novice programmers can adapt some of the simpler hash programming techniques as they develop their SAS programming skills. This book helps more experienced programmers learn how to take advantage of hash object programming by comparing traditional processing techniques to those that use hash objects. Additionally, users from diverse fields with different requirements can adapt the examples in SAS Hash Object Programming Made Easy to fit their unique situations. This book is part of the SAS Press program.

The Essential Guide to SAS Dates and Times Second Edition

Author: Derek P. Morgan
Publisher: SAS Institute
ISBN: 1629590665
Release Date: 2014-12-01
Genre: Computers

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.

Clinical Graphs Using SAS

Author: Sanjay Matange
Publisher: SAS Institute
ISBN: 9781629602059
Release Date: 2016-03-21
Genre: Computers

SAS users in the Health and Life Sciences industry need to create complex graphs to analyze biostatistics data and clinical data, and they need to submit drugs for approval to the FDA. Graphs used in the HLS industry are complex in nature and require innovative usage of the graphics features. Clinical Graphs Using SAS® provides the knowledge, the code, and real-world examples that enable you to create common clinical graphs using SAS graphics tools, such as the Statistical Graphics procedures and the Graph Template Language. This book describes detailed processes to create many commonly used graphs in the Health and Life Sciences industry. For SAS® 9.3 and SAS® 9.4 it covers many improvements in the graphics features that are supported by the Statistical Graphics procedures and the Graph Template Language, many of which are a direct result of the needs of the Health and Life Sciences community. With the addition of new features in SAS® 9.4, these graphs become positively easy to create. Topics covered include the usage of SGPLOT procedure, the SGPANEL procedure and the Graph Template Language for the creation of graphs like forest plots, swimmer plots, and survival plots.

Modern Approaches to Clinical Trials Using SAS Classical Adaptive and Bayesian Methods

Author: Sandeep Menon
Publisher: SAS Institute
ISBN: 9781629600826
Release Date: 2015-12-09
Genre: Mathematics

Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. Menon and Richard C. Zink, thoroughly covers several domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods that are applicable to and widely used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, the book touches on a wide variety of topics, including dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs that incorporate historical data; adaptive sample size re-estimation; adaptive randomization to allocate subjects to more effective treatments; and population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology, and rheumatology. Individual chapters are authored by renowned contributors, experts, and key opinion leaders from the pharmaceutical/medical device industry or academia. Numerous real-world examples and sample SAS code enable users to readily apply novel clinical trial design and analysis methodologies in practice.

Sample Size Calculations in Clinical Research Third Edition

Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 9781351727112
Release Date: 2017-08-15
Genre: Mathematics

Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." – Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation. ?

Clinical Trial Data Analysis Using R and SAS

Author: Ding-Geng (Din) Chen
Publisher: CRC Press
ISBN: 9781351651141
Release Date: 2017-06-01
Genre: Mathematics

Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods." —Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.

SAS Programming with Medicare Administrative Data

Author: Matthew Gillingham
Publisher: SAS Institute
ISBN: 9781629591537
Release Date: 2014-05-01
Genre: Mathematics

SAS Programming with Medicare Administrative Data is the most comprehensive resource available for using Medicare data with SAS. This book teaches you how to access Medicare data and, more importantly, how to apply this data to your research. Knowing how to use Medicare data to answer common research and business questions is a critical skill for many SAS users. Due to its complexity, Medicare data requires specific programming knowledge in order to be applied accurately. Programmers need to understand the Medicare program in order to interpret and utilize its data. With this book, you'll learn the entire process of programming with Medicare data—from obtaining access to data; to measuring cost, utilization, and quality; to overcoming common challenges. Each chapter includes exercises that challenge you to apply concepts to real-world programming tasks. SAS Programming with Medicare Administrative Data offers beginners a programming project template to follow from beginning to end. It also includes more complex questions and discussions that are appropriate for advanced users. Matthew Gillingham has created a book that is both a foundation for programmers new to Medicare data and a comprehensive reference for experienced programmers. This book is part of the SAS Press program.