PS10: Leading Through Transformation: Statistical Leadership in the AI/ML Era

The integration of artificial intelligence (AI) and machine learning (ML) into drug development has created unparalleled opportunities to revolutionize the field. However, this transformation demands not only technical excellence but also strategic leadership from statisticians. While these technologies offer immense potential, they also present challenges such as navigating regulatory expectations, ensuring data integrity, and fostering cross-functional collaboration. Statistical leaders are at the forefront of addressing these challenges, providing the expertise and strategic vision necessary to harness AI/ML's potential while maintaining rigor and reliability. This session brings together distinguished speakers from regulatory and industry perspectives to explore the pivotal role of statistical leadership in this transformative era. From the regulatory perspective, the discussion will delve into the statistical hurdles associated with AI/ML in drug development, emphasizing the importance of rigorous evaluation methods to ensure robust, reproducible, and reliable outcomes. From the industry perspective, the session will showcase how statistical stewardship is critical to managing the complexities of AI/ML integration in medicines development. By providing methodological rigor and fostering collaboration across disciplines, statisticians play a central role in embedding analytics across the drug development lifecycle, ensuring ethical and transparent application of AI/ML solutions. Together, these perspectives will offer attendees a comprehensive understanding of how statistical leaders navigate the opportunities and challenges of AI/ML to influence high-stakes decision-making, foster innovation, and uphold the rigor necessary for advancing drug development.