MATHEMATICAL AND STATISTICAL SKILLS IN THE BIOPHARMACEUTICAL INDUSTRY A PRAGMATIC APPROACH (HB 2020) Hardcover

Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach offers a practical perspective on effective problem solving in the context of biostatistics within clinical drug development. Drawing on the authors’ extensive experience in the biopharmaceutical sector, the book presents real-world insights and strategies aimed at enhancing efficiency and decision-making. Intended for biostatisticians at all career stages, as well as graduate students pursuing careers in this field, the book outlines a set of guiding principles tailored to real-life scenarios in drug development. It explores the varying roles of biostatisticians in both small and large pharmaceutical companies, emphasizes the crucial relationship between statistical programming, data management, and biostatistics, and introduces key statistical concepts applicable to the industry. The text also highlights trending topics in biostatistics, explains the limitations of relying solely on standard procedures and regulations, and introduces a new method for assessing safety outcomes in completed randomized clinical trials. Additionally, it showcases how these problem-solving methods have been applied to the complex field of transfusion research and discusses strategies for planning projects with uncertain timelines.