About Book
Biostatistics and Research Methodology form the backbone of evidence-based practice in health sciences, pharmacy, medicine, life sciences, and allied disciplines. In an era where data-driven decision-making governs clinical practice, pharmaceutical research, public health policy, and academic inquiry, a sound understanding of statistical principles and systematic research methods is no longer optional but essential. This book has been conceived and developed to address this critical need among undergraduate, postgraduate, and research scholars. The primary objective of this book is to present the concepts of biostatistics and research methodology in a clear, logical, and application-oriented manner. Each topic is explained in a stepwise manner, beginning with fundamental principles and progressing toward their application in biomedical and pharmaceutical research. Pedagogical features such as clearly defined learning objectives, illustrative tables, diagrams, solved examples, and end-of-chapter review questions have been incorporated to enhance comprehension and examination preparedness.
About Author
Mr. Raj Kumar Devarakonda is a Principal Statistical Programmer based in United States with over 15 years of experience supporting Phase I–IV clinical trials across multiple therapeutic areas, including oncology, dermatology, ophthalmology, respiratory, pain, and orphan diseases. He currently leads statistical programming efforts at Fortrea (formerly Labcorp), where he oversees complex SDTM and ADaM development, integrated analyses (ISS/ISE), regulatory-ready TFLs, and mentors programming teams while working closely with statisticians, data managers, and global clients. Over his career at Fortrea, IQVIA and The Boston Group, Raj has played a key role in delivering high-quality, CDISC compliant datasets, resolving regulatory validation issues, implementing advanced methods such as multiple imputation, and streamlining analysis workflows using SAS. He is an active contributor to the scientific community, with peer reviewed publications in biomedical research, invited presentations on response analysis datasets and missing data methodologies, and ongoing involvement in professional peer review. Raj holds a Master’s degree in Biomedical Engineering, is a Fellow of the Royal Statistical Society, a member of ASCO, IEEE, and other professional organizations and is an inventor on granted patents focused on AI-enabled automation of clinical trial data analysis and regulatory submission workflows, reflecting his commitment to innovation, rigor, and practical impact in clinical research and statistical publishing.