Search Results: sas-programming-in-the-pharmaceutical-industry-second-edition

SAS Programming in the Pharmaceutical Industry, Second Edition

Author: Jack Shostak

Publisher: SAS Institute

ISBN: 1629591491

Category: Mathematics

Page: 308

View: 4906

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.

Implementing CDISC Using SAS

An End-to-End Guide, Second Edition

Author: Chris Holland,Jack Shostak

Publisher: SAS Institute

ISBN: 1629605360

Category: Computers

Page: 294

View: 5365

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,Brian C. Shilling

Publisher: SAS Institute

ISBN: 1599941287

Category: Computers

Page: 206

View: 358

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

A Practical Guide

Author: Alex Dmitrienko,Christy Chuang-Stein,Ralph B. D'Agostino

Publisher: SAS Institute

ISBN: 1599943573

Category: Computers

Page: 464

View: 7345

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,Jack Shostak

Publisher: SAS Institute

ISBN: 1607644258

Category: Computers

Page: 552

View: 6131

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

A Practical Guide, Second Edition

Author: Alex Dmitrienko,Gary G. Koch

Publisher: SAS Institute

ISBN: 1635261449

Category: Computers

Page: 410

View: 9696

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

A Practical Guide to Design, Analysis, and Reporting

Author: Duolao Wang,Ameet Bakhai

Publisher: Remedica

ISBN: 1901346722

Category: Medical

Page: 480

View: 8346

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: 1612900984

Category: Mathematics

Page: 208

View: 4496

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.

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

Author: Sandeep Menon,Richard C. Zink

Publisher: SAS Institute

ISBN: 1629600822

Category: Mathematics

Page: 364

View: 795

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.

SAS Programming with Medicare Administrative Data

Author: Matthew Gillingham

Publisher: SAS Institute

ISBN: 162959153X

Category: Mathematics

Page: 168

View: 9768

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.

Adaptive Design Theory and Implementation Using SAS and R, Second Edition

Author: Mark Chang

Publisher: CRC Press

ISBN: 1482256592

Category: Mathematics

Page: 706

View: 2226

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

Author: Sanjay Matange

Publisher: SAS Institute

ISBN: 1629602051

Category: Computers

Page: 270

View: 847

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

Author: Shein-Chung Chow,Hansheng Wang,Jun Shao

Publisher: CRC Press

ISBN: 0824748239

Category: Mathematics

Page: 358

View: 6432

Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of discrepancies and how to avoid them. This volume provides formulas and procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It contains a comprehensive and unified presentation of statistical procedures for sample size calculation that are commonly employed at various phases of clinical development. Each chapter includes, whenever possible, real examples of clinical studies from therapeutic areas such as cardiovascular, central nervous system, anti-infective, oncology, and women's health to demonstrate the clinical and statistical concepts, interpretations, and their relationships and interactions. The book highlights statistical procedures for sample size calculation and justification that are commonly employed in clinical research and development. It provides clear, illustrated explanations of how the derived formulas and/or statistical procedures can be used.

Handbook of Statistics in Clinical Oncology, Third Edition

Author: John Crowley,Antje Hoering

Publisher: CRC Press

ISBN: 143986201X

Category: Mathematics

Page: 657

View: 6182

Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics relevant to these new advances in cancer research, this third edition of Handbook of Statistics in Clinical Oncology focuses on the design and analysis of oncology clinical trials and translational research. Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials, incorporating updates to all four parts: Phase I trials: Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches, along with new chapters on phase 0 trials and phase I trial design for targeted agents. Phase II trials: Updates to current experience in single-arm and randomized phase II trial designs. New chapters include phase II designs with multiple strata and phase II/III designs. Phase III trials: Many new chapters include interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials. Exploratory and high-dimensional data analyses: All chapters in this part have been thoroughly updated since the last edition. New chapters address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added. Accessible to statisticians and oncologists interested in clinical trial methodology, the book is a single-source collection of up-to-date statistical approaches to research in clinical oncology.

The Essential Guide to SAS Dates and Times, Second Edition

Author: Derek P. Morgan

Publisher: SAS Institute

ISBN: 9781629590660

Category: Computers

Page: 278

View: 2107

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.

Designing Clinical Research

Author: Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman

Publisher: Lippincott Williams & Wilkins

ISBN: 1469840545

Category: Medical

Page: 378

View: 2454

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This product incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing.

SAS Macro Programming Made Easy, Third Edition

Author: Michele M. Burlew

Publisher: SAS Institute

ISBN: 1629591513

Category: Mathematics

Page: 386

View: 8423

This book provides beginners with a thorough foundation in SAS macro programming. The macro facility is a popular part of SAS. Macro programming is a required skill for many SAS programming jobs, and the SAS Advanced Programming Certification Exam tests macro processing concepts. Whether you're looking to become certified, land a job, or increase your skills, you'll benefit from SAS Macro Programming Made Easy, Third Edition. By following Michele Burlew's examples and step-by-step instructions, you'll be able to rapidly perform repetitive programming tasks, to pass information between programming steps more easily, and to make your programming easier to read. Updated for SAS 9.4, this book teaches you the elements of the macro facility (macro variables, macro programs, macro language), how to write a macro program, techniques for macro programming, tips on using the macro facility, how the macro facility fits into SAS, and about the interfaces between the macro facility and other components of SAS. Beginning macro programmers will learn to write SAS macro programs quickly and efficiently. More experienced programmers will find this book useful to refresh their conceptual knowledge and expand on their macro programming skills. Ultimately, any user interested in automating their programs—including analysts, programmers, and report writers—will find Michele Burlew's book an excellent tutorial. This book is part of the SAS Press program.

Learning SAS in the Computer Lab

Author: Rebecca Elliott,Christopher Morrell

Publisher: Cengage Learning

ISBN: 0495559687

Category: Mathematics

Page: 320

View: 1169

LEARNING SAS IN THE COMPUTER LAB, 3RD EDITION, gets students up and running quickly with SAS. Explaining concepts and commands in clear steps, the authors provide SAS basics so students can successfully apply computing techniques to all types of statistics problems and acquire an appreciation of data analysis. This brief, affordable manual also ensures that students learn enough about programming with SAS to be able to find their way around the many SAS reference manuals that they will use in their professional activities. Important Notice: Media content referenced within the product description or the product text may not be available in the ebook version.

SAS For Dummies

Author: Stephen McDaniel,Chris Hemedinger

Publisher: John Wiley & Sons

ISBN: 9781118044018

Category: Computers

Page: 408

View: 3854

Created in partnership with SAS, this book explores SAS, a business intelligence software that can be used in any business setting or enterprise for data delivery, reporting, data mining, forecasting, statistical analysis, and more SAS employee and technologist Stephen McDaniel combines real-world expertise and a friendly writing style to introduce readers to SAS basics Covers crucial topics such as getting various types of data into the software, producing reports, working with the data, basic SAS programming, macros, and working with SAS and databases

Analysis of Observational Health Care Data Using SAS

Author: Douglas E. Faries,Robert Obenchain,Josep Maria Haro,Andrew C. Leon

Publisher: SAS Institute

ISBN: 9781607644248

Category: Computers

Page: 452

View: 7654

This book guides researchers in performing and presenting high-quality analyses of all kinds of non-randomized studies, including analyses of observational studies, claims database analyses, assessment of registry data, survey data, pharmaco-economic data, and many more applications. The text is sufficiently detailed to provide not only general guidance, but to help the researcher through all of the standard issues that arise in such analyses. Just enough theory is included to allow the reader to understand the pros and cons of alternative approaches and when to use each method. The numerous contributors to this book illustrate, via real-world numerical examples and SAS code, appropriate implementations of alternative methods. The end result is that researchers will learn how to present high-quality and transparent analyses that will lead to fair and objective decisions from observational data. This book is part of the SAS Press program.

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