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SAS Programming in the Pharmaceutical Industry Second Edition

SAS Programming in the Pharmaceutical Industry  Second Edition Author Jack Shostak
ISBN-10 9781629591490
Release 2014-03-01
Pages 308
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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

SAS Programming in the Pharmaceutical Industry Author Jack Shostak
ISBN-10 1590477936
Release 2005
Pages 332
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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

Implementing CDISC Using SAS Author Chris Holland
ISBN-10 9781629605364
Release 2016-11-28
Pages 294
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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.



Pharmaceutical Statistics Using SAS

Pharmaceutical Statistics Using SAS Author Alex Dmitrienko
ISBN-10 9781599943572
Release 2007
Pages 464
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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.



Validating Clinical Trial Data Reporting with SAS

Validating Clinical Trial Data Reporting with SAS Author Carol I. Matthews
ISBN-10 9781599941288
Release 2008
Pages 206
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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.



Analysis of Clinical Trials Using SAS

Analysis of Clinical Trials Using SAS Author Alex Dmitrienko
ISBN-10 9781635261448
Release 2017-07-17
Pages 410
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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.



Common Statistical Methods for Clinical Research with SAS Examples

Common Statistical Methods for Clinical Research with SAS Examples Author Glenn A. Walker
ISBN-10 9781607644255
Release 2010-02
Pages 552
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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.



Clinical Trials

Clinical Trials Author Duolao Wang
ISBN-10 9781901346725
Release 2006
Pages 480
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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.



How to Become a Top SAS Programmer

How to Become a Top SAS Programmer Author Michael A. Raithel
ISBN-10 9781612901046
Release 2013-08-19
Pages 184
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How to Become a Top SAS Programmer is designed to help SAS programmers maximize their value to an organization. Users will gain a better understanding of the SAS resources available to them so that they can enhance their SAS skills and knowledge, thereby becoming better SAS programmers. How to Become a Top SAS Programmer is designed to help SAS programmers maximize their value to an organization. Users will gain a better understanding of the SAS resources available to them so that they can enhance their SAS skills and knowledge, thereby becoming better SAS programmers.



Longitudinal Data and SAS

Longitudinal Data and SAS Author Ron Cody
ISBN-10 1590474295
Release 2001-10-01
Pages 208
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Working with longitudinal data introduces a unique set of challenges. Once you've mastered the art of performing calculations within a single observation of a data set, you're faced with the task of performing calculations or making comparisons between observations. It's easy to look backward in data sets, but how do you look forward and across observations? Ron Cody provides straightforward answers to these and other questions. Longitudinal Data and SAS details useful techniques for conducting operations between observations in a SAS data set. For quick reference, the book is conveniently organized to cover tools-an introduction to powerful SAS programming techniques for longitudinal data; case studies-a variety of illuminating examples that use Ron's techniques; and macros-detailed descriptions of helpful longitudinal data macros. Beginning to intermediate SAS users will appreciate this book's informative, easy-to-comprehend style. And users who frequently process longitudinal data will learn to make the most of their analyses by following Ron's methodologies.



Carpenter s Guide to Innovative SAS Techniques

Carpenter s Guide to Innovative SAS Techniques Author Art Carpenter
ISBN-10 9781612902029
Release 2012-03-02
Pages 570
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Carpenter's Guide to Innovative SAS Techniques offers advanced SAS programmers an all-in-one programming reference that includes advanced topics not easily found outside the depths of SAS documentation or more advanced training classes. Art Carpenter has written fifteen chapters of advanced tips and techniques, including topics on data summary, data analysis, and data reporting. Special emphasis is placed on DATA step techniques that solve complex data problems. There are numerous examples that illustrate advanced techniques that take advantage of formats, interface with the macro language, and utilize the Output Delivery System. Additional topics include operating system interfaces, table lookup techniques, and the creation of customized reports.



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

Modern Approaches to Clinical Trials Using SAS  Classical  Adaptive  and Bayesian Methods Author Sandeep Menon
ISBN-10 9781629600826
Release 2015-12-09
Pages 364
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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.



Adaptive Design Theory and Implementation Using SAS and R Second Edition

Adaptive Design Theory and Implementation Using SAS and R  Second Edition Author Mark Chang
ISBN-10 9781482256598
Release 2014-12-01
Pages 706
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Get Up to Speed on Many Types of Adaptive Designs Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. New to the Second Edition Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more More analytical methods for K-stage adaptive designs, multiple-endpoint adaptive design, survival modeling, and adaptive treatment switching New material on sequential parallel designs with rerandomization and the skeleton approach in adaptive dose-escalation trials Twenty new SAS macros and R functions Enhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trials Covering even more adaptive designs, this book provides biostatisticians, clinical scientists, and regulatory reviewers with up-to-date details on this innovative area in pharmaceutical research and development. Practitioners will be able to improve the efficiency of their trial design, thereby reducing the time and cost of drug development.



Clinical Graphs Using SAS

Clinical Graphs Using SAS Author Sanjay Matange
ISBN-10 9781629602059
Release 2016-03-21
Pages 270
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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.



Sample Size Calculations in Clinical Research Third Edition

Sample Size Calculations in Clinical Research  Third Edition Author Shein-Chung Chow
ISBN-10 9781351727112
Release 2017-08-15
Pages 510
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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. ?



SAS Certification Prep Guide

SAS Certification Prep Guide Author SAS Institute
ISBN-10 9781635264685
Release 2018-01-12
Pages 582
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Prepare for the SAS Base Programming for SAS 9 exam with the official guide by the SAS Global Certification Program. New and experienced SAS users who want to prepare for the SAS Base Programming for SAS 9 exam will find this guide to be an invaluable, convenient, and comprehensive resource that covers all of the objectives tested on the exam. Now in its fourth edition, the guide has been extensively updated, and revised to streamline explanations. Major topics include importing and exporting raw data files, creating and modifying SAS data sets, and identifying and correcting data syntax and programming logic errors. The chapter quizzes have been thoroughly updated and full solutions are included at the back of the book. In addition, links are provided to the exam objectives, practice exams, and other helpful resources, such as the updated Base SAS glossary and an expanded collection of practice data sets. Content updates are available here.



The Essential Guide to SAS Dates and Times

The Essential Guide to SAS Dates and Times Author Derek P. Morgan
ISBN-10 9781599941066
Release 2006
Pages 172
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Why does SAS use January 1, 1960, as its arbitrary reference date? How do you convert a value such as 27 January 2003 into SAS dates? You'll find the answers to these questions and much more in Derek Morgan's Essential Guide to SAS Dates and Times, which makes it easy to understand how to use and manipulate dates, times, and datetimes in SAS. Novice-to-intermediate users will find the clear, task-focused examples and explanations of formats and functions invaluable; experienced users will appreciate discussions of topics such as intervals and international date and time formats. Included is a bonus "Quick Reference Guide" listing all the formats (with examples) on one handy page. This book is part of the SAS Press program.