Statistical Thinking for Non-Statisticians in Drug Regulation: A Comprehensive Guide

Statistical methods are a cornerstone of the pharmaceutical industry, playing a crucial 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 becomes essential for valid conclusions.

In today’s fast-paced drug development landscape, 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, need a solid understanding of statistical methodology to make informed decisions.

About the Book

Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive, in-depth guide to statistical methodology, tailored specifically for pharmaceutical industry professionals. The authors’ extensive experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential resource for those working in and with the industry.

What’s New in the Third Edition

• A detailed new chapter on Estimands, aligned with the 2019 Addendum to ICH E9
• Major new sections on 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 ideal for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.

Product Details

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

Stay ahead in the pharmaceutical industry with Statistical Thinking for Non-Statisticians in Drug Regulation – the ultimate resource for professionals seeking to enhance their understanding of statistical methodology and drive success in drug development and regulation.