Dr. Cong Chen is the Scientific AVP of Early Oncology Statistics at Merck Sharp & Dohme. In this role, he provides fit-for-purpose decision-making strategies and innovative statistical methodologies to support oncology clinical development programs. His work spans internal pipeline development, external collaborations, and high-profile due diligence initiatives. Prior to assuming this position, Dr. Chen led the statistical efforts behind the development of Keytruda, playing a pivotal role in accelerating its regulatory approvals. He is an elected Fellow of American Statistical Association (2016), an Associate Editor of Statistics in Biopharmaceutical Research, a member of Cancer Clinical Research Editorial Board and a leader of the DIA Innovative Design Working Group. He has published over 110 papers and 10 book chapters on innovative design and analysis methods of clinical trials. He has also given multiple short courses on this subject at statistical conferences and is a frequent speaker and panelist at major clinical conferences, focusing on statistical design strategies and regulatory policy for oncology drug development.