Implementing CDISC Using SAS

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Author :
Publisher : SAS Institute
ISBN 13 : 1642952419
Total Pages : 294 pages
Book Rating : 4.6/5 (429 download)

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Book Synopsis Implementing CDISC Using SAS by : Chris Holland

Download or read book Implementing CDISC Using SAS written by Chris Holland and published by SAS Institute. This book was released on 2019-05-30 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, Revised 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 edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, STDM and ADAM metadata spreadsheets, and of course new versions of SAS and JMP software. The second edition was revised to add the latest C-Codes from the most recent release as well as update the make_define macro that accompanies this book in order to add the capability to handle C-Codes. The metadata spreadsheets were updated accordingly. 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.

Clinical Data Quality Checks for CDISC Compliance Using SAS

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Author :
Publisher : CRC Press
ISBN 13 : 1000699048
Total Pages : 156 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Clinical Data Quality Checks for CDISC Compliance Using SAS by : Sunil Gupta

Download or read book Clinical Data Quality Checks for CDISC Compliance Using SAS written by Sunil Gupta and published by CRC Press. This book was released on 2019-09-23 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Data Quality Checks for CDISC Compliance using SAS is the first book focused on identifying and correcting data quality and CDISC compliance issues with real-world innovative SAS programming techniques such as Proc SQL, metadata and macro programming. Learn to master Proc SQL’s subqueries and summary functions for multi-tasking process. Drawing on his more than 25 years’ experience in the pharmaceutical industry, the author provides a unique approach that empowers SAS programmers to take control of data quality and CDISC compliance. This book helps you create a system of SDTM and ADaM checks that can be tracked for continuous improvement. How often have you encountered issues such as missing required variables, duplicate records, invalid derived variables and invalid sequence of two dates? With the SAS programming techniques introduced in this book, you can start to monitor these and more complex data and CDISC compliance issues. With increased standardization in SDTM and ADaM specifications and data values, codelist dictionaries can be created for better organization, planning and maintenance. This book includes a SAS program to create excel files containing unique values from all SDTM and ADaM variables as columns. In addition, another SAS program compares SDTM and ADaM codelist dictionaries with codelists from define.xml specifications. Having tools to automate this process greatly saves time from doing it manually. Features SDTMs and ADaMs Vitals SDTMs and ADaMs Data CDISC Specifications Compliance CDISC Data Compliance Protocol Compliance Codelist Dictionary Compliance

Validating Clinical Trial Data Reporting with SAS

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Publisher : SAS Institute
ISBN 13 : 1599941287
Total Pages : 229 pages
Book Rating : 4.5/5 (999 download)

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Book Synopsis Validating Clinical Trial Data Reporting with SAS by : Carol I. Matthews

Download or read book Validating Clinical Trial Data Reporting with SAS written by Carol I. Matthews and published by SAS Institute. This book was released on 2008 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Implementing CDISC Using SAS

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Publisher : Sas Inst
ISBN 13 : 9781612901657
Total Pages : 264 pages
Book Rating : 4.9/5 (16 download)

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Book Synopsis Implementing CDISC Using SAS by : Chris Holland

Download or read book Implementing CDISC Using SAS written by Chris Holland and published by Sas Inst. This book was released on 2012-11-23 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have written 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 is an all-inclusive guide on how to implement and analyze Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submissions. Topics covered include 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. Anyone dealing with CDISC standards--including SAS or JMP programmers, statisticians, and data managers in the pharmaceutical, biotechnology, or medical device industries--will find the philosophical best practices and implementation examples in this book invaluable.SAS Products and Releases: Base SAS: 9.3 JMP: 9.0.2, 10.0.2, 10.0.1, 10.0 JMP Clinical: 4.0, 3.1, 3.0, 2.1 SAS Clinical Data Integration: 2.3 SAS Clinical Standards Toolkit: 1.4, 1.3, 1.2 Operating Systems: All

Implementing CDISC Using SAS

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Publisher :
ISBN 13 : 9781642952230
Total Pages : 308 pages
Book Rating : 4.9/5 (522 download)

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Book Synopsis Implementing CDISC Using SAS by : Chris Holland

Download or read book Implementing CDISC Using SAS written by Chris Holland and published by . This book was released on 2020-07-24 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

SAS Clinical Programming

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Author :
Publisher : Notion Press
ISBN 13 : 9384381896
Total Pages : 459 pages
Book Rating : 4.3/5 (843 download)

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Book Synopsis SAS Clinical Programming by : Y. LAKSHMI PRASAD

Download or read book SAS Clinical Programming written by Y. LAKSHMI PRASAD and published by Notion Press. This book was released on 2014-09-12 with total page 459 pages. Available in PDF, EPUB and Kindle. Book excerpt: An indispensable guide to SAS Clinical Programming, this book is the first guide on this topic, to be written by an Indian author. Written in an instructive and conversational tone for people who want to make their career in SAS Clinical Programming and entry level programmers for their day-to-day tasks. It is equipped with practical, real world examples, detailed description of programs, work flows, issues, resolutions and key techniques. This book is a personal SAS Clinical trainer. It explains the art of SAS Clinical Programming in eighteen easy steps, covering everything from basics to ADS, TLF Creation, as well as CDISC SDTM and ADaM specifications. Many statistical concepts are explained in an easy way so that you feel confident while using Statistical Procedures. If you are already working as a SAS Clinical Programmer, this book will aid you with sharpening your skills.

Clinical Trials

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Author :
Publisher : Remedica
ISBN 13 : 1901346722
Total Pages : 497 pages
Book Rating : 4.9/5 (13 download)

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Book Synopsis Clinical Trials by : Duolao Wang

Download or read book Clinical Trials written by Duolao Wang and published by Remedica. This book was released on 2006 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.

Common Statistical Methods for Clinical Research with SAS Examples, Third Edition

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Author :
Publisher : SAS Institute
ISBN 13 : 1607644258
Total Pages : 553 pages
Book Rating : 4.6/5 (76 download)

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Book Synopsis Common Statistical Methods for Clinical Research with SAS Examples, Third Edition by : Glenn Walker

Download or read book Common Statistical Methods for Clinical Research with SAS Examples, Third Edition written by Glenn Walker and published by SAS Institute. This book was released on 2010-02-15 with total page 553 pages. Available in PDF, EPUB and Kindle. Book excerpt: Glenn Walker and Jack Shostak's Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is a 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. Straightforward and easy to use as either a text or a reference, the book is full of practical examples from clinical research to illustrate both statistical and SAS methodology. Each example is worked out completely, step by step, from the raw data. Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is an applications book with minimal theory. Each section begins with an overview helpful to nonstatisticians and then drills down into details that will be valuable to statistical analysts and programmers. Further details, as well as bonus information and a guide to further reading, are presented in the extensive appendices. This text is a one-source guide for statisticians that documents the use of the tests used most often in clinical research, with assumptions, details, and some tricks--all in one place. This book is part of the SAS Press program.

SAS Programming in the Pharmaceutical Industry, Second Edition

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Publisher : SAS Institute
ISBN 13 : 1629591491
Total Pages : 308 pages
Book Rating : 4.6/5 (295 download)

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Book Synopsis SAS Programming in the Pharmaceutical Industry, Second Edition by : Jack Shostak

Download or read book SAS Programming in the Pharmaceutical Industry, Second Edition written by Jack Shostak and published by SAS Institute. This book was released on 2014-03-01 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

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Publisher :
ISBN 13 : 9781590477939
Total Pages : 0 pages
Book Rating : 4.4/5 (779 download)

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Book Synopsis SAS Programming in the Pharmaceutical Industry by : Jack Shostak

Download or read book SAS Programming in the Pharmaceutical Industry written by Jack Shostak and published by . This book was released on 2005 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

SAS Graphics for Clinical Trials by Example

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Author :
Publisher : SAS Institute
ISBN 13 : 195236597X
Total Pages : 198 pages
Book Rating : 4.9/5 (523 download)

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Book Synopsis SAS Graphics for Clinical Trials by Example by : Kriss Harris

Download or read book SAS Graphics for Clinical Trials by Example written by Kriss Harris and published by SAS Institute. This book was released on 2020-11-25 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: Create industry-compliant graphs with this practical guide for professionals Analysis of clinical trial results is easier when the data is presented in a visual form. However, clinical graphs must conform to specific guidelines in order to satisfy regulatory agency requirements. If you are a programmer working in the health care and life sciences industry and you want to create straightforward, visually appealing graphs using SAS, then this book is designed specifically for you. Written by two experienced practitioners, the book explains why certain graphs are requested, gives the necessary code to create the graphs, and shows you how to create graphs from ADaM data sets modeled on real-world CDISC pilot study data. SAS Graphics for Clinical Trials by Example demonstrates step-by-step how to create both simple and complex graphs using Graph Template Language (GTL) and statistical graphics procedures, including the SGPLOT and SGPANEL procedures. You will learn how to generate commonly used plots such as Kaplan-Meier plots and multi-cell survival plots as well as special purpose graphs such as Venn diagrams and interactive graphs. Because your graph is only as good as the aesthetic appearance of the output, you will learn how to create a custom style, change attributes, and set output options. Whether you are just learning how to produce graphs or have been working with graphs for a while, this book is a must-have resource to solve even the most challenging clinical graph problems.

Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS

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Author :
Publisher : SAS Institute
ISBN 13 : 1629592331
Total Pages : 268 pages
Book Rating : 4.6/5 (295 download)

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Book Synopsis Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS by : Richard C. Zink

Download or read book Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS written by Richard C. Zink and published by SAS Institute. This book was released on 2014-07-01 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improve efficiency while reducing costs in clinical trials with centralized monitoring techniques using JMP and SAS. International guidelines recommend that clinical trial data should be actively reviewed or monitored; the well-being of trial participants and the validity and integrity of the final analysis results are at stake. Traditional interpretation of this guidance for pharmaceutical trials has led to extensive on-site monitoring, including 100% source data verification. On-site review is time consuming, expensive (estimated at up to a third of the cost of a clinical trial), prone to error, and limited in its ability to provide insight for data trends across time, patients, and clinical sites. In contrast, risk-based monitoring (RBM) makes use of central computerized review of clinical trial data and site metrics to determine if and when clinical sites should receive more extensive quality review or intervention. Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS presents a practical implementation of methodologies within JMP Clinical for the centralized monitoring of clinical trials. Focused on intermediate users, this book describes analyses for RBM that incorporate and extend the recommendations of TransCelerate Biopharm Inc., methods to detect potential patient-or investigator misconduct, snapshot comparisons to more easily identify new or modified data, and other novel visual and analytical techniques to enhance safety and quality reviews. Further discussion highlights recent regulatory guidance documents on risk-based approaches, addresses the requirements for CDISC data, and describes methods to supplement analyses with data captured external to the study database. Given the interactive, dynamic, and graphical nature of JMP Clinical, any individual from the clinical trial team - including clinicians, statisticians, data managers, programmers, regulatory associates, and monitors - can make use of this book and the numerous examples contained within to streamline, accelerate, and enrich their reviews of clinical trial data. The analytical methods described in Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS enable the clinical trial team to take a proactive approach to data quality and safety to streamline clinical development activities and address shortcomings while the study is ongoing. This book is part of the SAS Press

SAS Certified Professional Prep Guide

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Author :
Publisher : SAS Institute
ISBN 13 : 1642954691
Total Pages : 634 pages
Book Rating : 4.6/5 (429 download)

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Book Synopsis SAS Certified Professional Prep Guide by : SAS Institute

Download or read book SAS Certified Professional Prep Guide written by SAS Institute and published by SAS Institute. This book was released on 2019-10-18 with total page 634 pages. Available in PDF, EPUB and Kindle. Book excerpt: The official guide by the SAS Global Certification Program, SAS Certified Professional Prep Guide: Advanced Programming Using SAS 9.4 prepares you to take the new SAS 9.4 Advanced Programming Performance-Based Exam. New in this edition is a workbook whose sample scenarios require you to write code to solve problems and answer questions. Answers to the chapter quizzes and solutions to the sample scenarios in the workbook are included. You will also find links to exam objectives, practice exams, and other resources such as the Base SAS Glossary and a list of practice data sets. Major topics include SQL processing, SAS macro language processing, and advanced SAS programming techniques. All exam topics are covered in the following chapters: SQL Processing with SAS PROC SQL Fundamentals Creating and Managing Tables Joining Tables Using PROC SQL Joining Tables Using Set Operators Using Subqueries Advanced SQL Techniques SAS Macro Language Processing Creating and Using Macro Variables Storing and Processing Text Working with Macro Programs Advanced Macro Techniques Advanced SAS Programming Techniques Defining and Processing Arrays Processing Data Using Hash Objects Using SAS Utility Procedures Using Advanced Functions Practice Programming Scenarios (Workbook)

Principles and Practice of Clinical Trials

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Author :
Publisher : Springer Nature
ISBN 13 : 3319526367
Total Pages : 2573 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis Principles and Practice of Clinical Trials by : Steven Piantadosi

Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

The Book of R

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Author :
Publisher : No Starch Press
ISBN 13 : 1593277792
Total Pages : 833 pages
Book Rating : 4.5/5 (932 download)

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Book Synopsis The Book of R by : Tilman M. Davies

Download or read book The Book of R written by Tilman M. Davies and published by No Starch Press. This book was released on 2016-07-16 with total page 833 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Book of R is a comprehensive, beginner-friendly guide to R, the world’s most popular programming language for statistical analysis. Even if you have no programming experience and little more than a grounding in the basics of mathematics, you’ll find everything you need to begin using R effectively for statistical analysis. You’ll start with the basics, like how to handle data and write simple programs, before moving on to more advanced topics, like producing statistical summaries of your data and performing statistical tests and modeling. You’ll even learn how to create impressive data visualizations with R’s basic graphics tools and contributed packages, like ggplot2 and ggvis, as well as interactive 3D visualizations using the rgl package. Dozens of hands-on exercises (with downloadable solutions) take you from theory to practice, as you learn: –The fundamentals of programming in R, including how to write data frames, create functions, and use variables, statements, and loops –Statistical concepts like exploratory data analysis, probabilities, hypothesis tests, and regression modeling, and how to execute them in R –How to access R’s thousands of functions, libraries, and data sets –How to draw valid and useful conclusions from your data –How to create publication-quality graphics of your results Combining detailed explanations with real-world examples and exercises, this book will provide you with a solid understanding of both statistics and the depth of R’s functionality. Make The Book of R your doorway into the growing world of data analysis.

Learning SAS by Example

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Author :
Publisher : SAS Institute
ISBN 13 : 1635266564
Total Pages : 536 pages
Book Rating : 4.6/5 (352 download)

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Book Synopsis Learning SAS by Example by : Ron Cody

Download or read book Learning SAS by Example written by Ron Cody and published by SAS Institute. This book was released on 2018-07-03 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn to program SAS by example! Learning SAS by Example, A Programmer’s Guide, Second Edition, teaches SAS programming from very basic concepts to more advanced topics. Because most programmers prefer examples rather than reference-type syntax, this book uses short examples to explain each topic. The second edition has brought this classic book on SAS programming up to the latest SAS version, with new chapters that cover topics such as PROC SGPLOT and Perl regular expressions. This book belongs on the shelf (or e-book reader) of anyone who programs in SAS, from those with little programming experience who want to learn SAS to intermediate and even advanced SAS programmers who want to learn new techniques or identify new ways to accomplish existing tasks. In an instructive and conversational tone, author Ron Cody clearly explains each programming technique and then illustrates it with one or more real-life examples, followed by a detailed description of how the program works. The text is divided into four major sections: Getting Started, DATA Step Processing, Presenting and Summarizing Your Data, and Advanced Topics. Subjects addressed include Reading data from external sources Learning details of DATA step programming Subsetting and combining SAS data sets Understanding SAS functions and working with arrays Creating reports with PROC REPORT and PROC TABULATE Getting started with the SAS macro language Leveraging PROC SQL Generating high-quality graphics Using advanced features of user-defined formats and informats Restructuring SAS data sets Working with multiple observations per subject Getting started with Perl regular expressions You can test your knowledge and hone your skills by solving the problems at the end of each chapter.

Adaptive Design Theory and Implementation Using SAS and R

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Author :
Publisher : CRC Press
ISBN 13 : 1482256606
Total Pages : 689 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Adaptive Design Theory and Implementation Using SAS and R by : Mark Chang

Download or read book Adaptive Design Theory and Implementation Using SAS and R written by Mark Chang and published by CRC Press. This book was released on 2014-12-01 with total page 689 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get Up to Speed on Many Types of Adaptive DesignsSince 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