Abstract: Drug development constitutes a highly regulated and resource-intensive endeavor, in which statisticians assume a pivotal role in promoting rigorous quantitative decision-making throughout the entire pharmaceutical pipeline. This talk highlights key factors essential for successful statistical engagement, including the necessity of early involvement, deep interdisciplinary collaboration, strong communication skills, technical mastery of both classical and emerging statistical methodologies, organizational support, and an innovation-oriented mindset that effectively balances cutting-edge approaches with practical implementation. Illustrative examples are provided to demonstrate recent trends in statistical innovation and its potential influence on advancing development of new medicines.

About the Speaker: Demissie Alemayehu, Ph.D., is currently Head of Statistical Research and Data Science Center (SRDC) in the Global Biometrics and Data Management organization at Pfizer Inc. He has over 25 years of leadership experience in the pharmaceutical industry, and has held positions of increasing responsibility within Pfizer since 1995.

Over the years, he has been involved in extensive regulatory submissions and life-cycle management in major therapeutic areas. Demissie has been influential externally, with decades of research and teaching experience at major institutions, including Western Michigan and Columbia universities. He has held important offices at key professional societies, and has served on editorial boards of major journals.

He is an elected Fellow of the American Statistical Association, and holds a Ph.D. degree in Statistics from the University of California at Berkeley. He has published extensively on pertinent statistical topics in refereed journals, and his current areas of focus include precision medicine, Big Data analytics, and health technology assessment.