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Thought Leader: Dr. Alexandra Hanlon is the Director of the Center for Biostatistics and Health Data Science and a Professor of Practice at Virginia Tech. She brings extensive experience in clinical trial design, collaborative health science research, and biostatistical leadership. Her recent work has focused on advancing the role of statisticians in public health, particularly through high-impact projects such as the COVID-19 vaccine trials under Operation Warp Speed. Topic Overview: This session explores the pivotal role of statisticians in designing and executing the Phase III COVID-19 vaccine efficacy trials. Dr. Hanlon discusses key elements of trial design, including protocol development, endpoint selection, sample size calculation, interim monitoring, and primary statistical methods. She also highlights the accelerated timeline enabled by harmonized efforts, and how immune correlates are shaping the future of vaccine research. The talk provides valuable insights for anyone interested in public health, biostatistics, or clinical trial innovation.