"This is a highly original, extremely interesting, and in many ways impressive book. Its matter is largely about what it entails to be a professional biostatistician (in the widest sense of the word): what skills and attitudes you need to solve the problems encountered in exercising your profession. It is clear that the authors have thought long and hard about the problems they present. The case-studies are real, complex, interesting, and instructive. The book could only have been written by skilled scientists with long experience of working in the pharmaceutical industry. The reader benefits from the authors’ experience. The reader can be in no doubt that he or she is in the hands of experts. I learned a lot from the book." ~Stephen Senn, Retired, Honorary Professor, University of Sheffield" . . . the book is extremely well written in an accessible and entertaining style, while being informative at the same time. It can wholeheartedly be recommended to every early career biostatistician and PhD student in (bio)statistics, who is considering going into pharmaceutical research, or conducting research in clinical trials." ~Diane Uschner, ISCB News"The book is based on the author’s cumulative experience in the biopharmaceutical industry and wisdom gained from a myriad of challenging problems. Further, given the diverse set of covered topics, we feel that this book would benefit those new to the industry (e.g., graduate students), as well as experienced professionals. Through detailed case studies, the book covers the broad skill set that is needed in the biopharmaceutical industry. Covered clinical drug development topics include: the early stage (e.g., pharmacology, toxicology, pharmacokinetics), the late stage (e.g., trial management and analysis, investigational new drug or new drug applications, communications with regulatory), strategic planning, the functional role of biostatisticians within a biopharmaceutical company, and the many functional roles that a biostatistician must interact with. "The whole reading journey turned out to be a pleasant and educational one…For readers who are interested or are already in the biopharmaceutical industry, this book can provide a framework that helps you build a successful career in this dynamic and exciting industry." ~American Statistician
