Mastering Statistical Thinking in Drug Regulation: A Comprehensive Guide

In the pharmaceutical industry, statistical methods play a vital role in the design and analysis of clinical studies. As the medical and scientific community increasingly recognizes the importance of correct statistical methodology, effective communication across disciplines is crucial for valid conclusions.

The importance of statistical thinking cannot be overstated. It is essential for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers, and those working in pharmacovigilance, to understand and apply statistical methods correctly.

About the Book

Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive, in-depth guide to statistical methodology for pharmaceutical industry professionals. Written by experienced authors with up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community, this book is an essential resource for those working in and with the industry.

What’s New in the Third Edition

• A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9
• Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis
• Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience

This valuable guide is designed for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development. With its comprehensive coverage of statistical methodology, Statistical Thinking for Non-Statisticians in Drug Regulation is an indispensable resource for anyone working in the field.

Product Details

• Publisher: Wiley-Blackwell
• Edition: 3rd edition (December 13, 2022)
• Language: English
• Format: Hardcover
• Pages: 432
• ISBN-10: 111986738X
• ISBN-13: 978-1119867388