Michael P. Fay is a Mathematical Statistician at the National Institute of Allergy and Infectious Diseases, and previously worked at the National Cancer Institute. He has served as associate editor for Biometrics, and is currently an associate editor for Clinical Trials and a Fellow of the American Statistical Association. He is a co-author on over 100 papers in statistical and medical journals and has written and maintains over a dozen R packages on CRAN. Erica H. Brittain is Deputy Branch Chief of Biostatistics Research at the National Institute of Allergy and Infectious Diseases and has well over three decades of experience as a statistician, with previous positions at FDA, National Heart, Lung, and Blood Institute, and a statistical consulting company. Her applied work at NIH and her methodological publications in statistical journals focus on innovation in clinical trial design. She frequently serves on advisory panels for FDA and NIH, and has served as Statistical Consultant for Nature journals and Associate Editor for Controlled Clinical Trials.

'A necessary book for the applied statistician seeking to understand the theoretical underpinnings of statistical methods and for graduate students knowledgeable about statistical theory but lacking experience in application. The book is chock full of challenging examples that point to the complexities of choice of method. A particularly valuable feature of the book is the authors' description of competing methods coupled with their clarity in explaining and justifying why they prefer one method over others. Fay and Brittain should sit on every statistician's bookshelf.' Janet Wittes, WCG Statistics Collaborative

• 1. Introduction; 2. Theory of tests, p-values, and confidence intervals; 3. From scientific theory to statistical hypothesis test; 4. One sample studies with binary responses; 5. One sample studies with ordinal or numeric responses; 6. Paired data; 7. Two sample studies with binary responses; 8. Assumptions and hypothesis tests; 9. Two sample studies with ordinal or numeric responses; 10. General methods for creating decision rules; 11. K-Sample studies and trend tests; 12. Clustering and stratification; 13. Multiplicity in testing; 14. Testing from models; 15. Causality; 16. Censoring; 17. Missing data; 18. Group sequential and related adaptive methods; 19. Testing fit, equivalence, and non-inferiority; 20. Power and sample size.

Michael P. Fay is a Mathematical Statistician at the National Institute of Allergy and Infectious Diseases, and previously worked at the National Cancer Institute. He has served as associate editor for Biometrics, and is currently an associate editor for Clinical Trials and a Fellow of the American Statistical Association. He is a co-author on over 100 papers in statistical and medical journals and has written and maintains over a dozen R packages on CRAN. Erica H. Brittain is Deputy Branch Chief of Biostatistics Research at the National Institute of Allergy and Infectious Diseases and has well over three decades of experience as a statistician, with previous positions at FDA, National Heart, Lung, and Blood Institute, and a statistical consulting company. Her applied work at NIH and her methodological publications in statistical journals focus on innovation in clinical trial design. She frequently serves on advisory panels for FDA and NIH, and has served as Statistical Consultant for Nature journals and Associate Editor for Controlled Clinical Trials.

'A necessary book for the applied statistician seeking to understand the theoretical underpinnings of statistical methods and for graduate students knowledgeable about statistical theory but lacking experience in application. The book is chock full of challenging examples that point to the complexities of choice of method. A particularly valuable feature of the book is the authors' description of competing methods coupled with their clarity in explaining and justifying why they prefer one method over others. Fay and Brittain should sit on every statistician's bookshelf.' Janet Wittes, WCG Statistics Collaborative

• 1. Introduction; 2. Theory of tests, p-values, and confidence intervals; 3. From scientific theory to statistical hypothesis test; 4. One sample studies with binary responses; 5. One sample studies with ordinal or numeric responses; 6. Paired data; 7. Two sample studies with binary responses; 8. Assumptions and hypothesis tests; 9. Two sample studies with ordinal or numeric responses; 10. General methods for creating decision rules; 11. K-Sample studies and trend tests; 12. Clustering and stratification; 13. Multiplicity in testing; 14. Testing from models; 15. Causality; 16. Censoring; 17. Missing data; 18. Group sequential and related adaptive methods; 19. Testing fit, equivalence, and non-inferiority; 20. Power and sample size.

Michael P. Fay is a Mathematical Statistician at the National Institute of Allergy and Infectious Diseases, and previously worked at the National Cancer Institute. He has served as associate editor for Biometrics, and is currently an associate editor for Clinical Trials and a Fellow of the American Statistical Association. He is a co-author on over 100 papers in statistical and medical journals and has written and maintains over a dozen R packages on CRAN. Erica H. Brittain is Deputy Branch Chief of Biostatistics Research at the National Institute of Allergy and Infectious Diseases and has well over three decades of experience as a statistician, with previous positions at FDA, National Heart, Lung, and Blood Institute, and a statistical consulting company. Her applied work at NIH and her methodological publications in statistical journals focus on innovation in clinical trial design. She frequently serves on advisory panels for FDA and NIH, and has served as Statistical Consultant for Nature journals and Associate Editor for Controlled Clinical Trials.

'A necessary book for the applied statistician seeking to understand the theoretical underpinnings of statistical methods and for graduate students knowledgeable about statistical theory but lacking experience in application. The book is chock full of challenging examples that point to the complexities of choice of method. A particularly valuable feature of the book is the authors' description of competing methods coupled with their clarity in explaining and justifying why they prefer one method over others. Fay and Brittain should sit on every statistician's bookshelf.' Janet Wittes, WCG Statistics Collaborative

• 1. Introduction; 2. Theory of tests, p-values, and confidence intervals; 3. From scientific theory to statistical hypothesis test; 4. One sample studies with binary responses; 5. One sample studies with ordinal or numeric responses; 6. Paired data; 7. Two sample studies with binary responses; 8. Assumptions and hypothesis tests; 9. Two sample studies with ordinal or numeric responses; 10. General methods for creating decision rules; 11. K-Sample studies and trend tests; 12. Clustering and stratification; 13. Multiplicity in testing; 14. Testing from models; 15. Causality; 16. Censoring; 17. Missing data; 18. Group sequential and related adaptive methods; 19. Testing fit, equivalence, and non-inferiority; 20. Power and sample size.