Parallel Session #4b: The Strategic Partner: Mastering Data-Driven Decision Influence
Leadership
Friday, November 6 · 3:10 PM–4:40 PM
Session Chairs
Talks
Beyond the AI Proof of Concept: Building a Center of Data Excellence for Drug Development
Artificial intelligence is rapidly entering clinical development through applications ranging from protocol and EDC development to programming, analysis, medical review, and clinical study report generation. However, the greatest challenge may not be identifying promising AI tools — it is determining how organizations move from isolated proofs of concept to capabilities that are reliable, scalable, governed, and embedded within the way drug development teams make decisions. This presentation will discuss lessons from building and evaluating AI-enabled workflows within clinical development and explore the concept of an AI-enabled Center of Data Excellence.
Influencing Across Complexity in Projects
Project leads often face situations where technical, operational, and regulatory teams have competing priorities. This presentation explores three pivotal moments — disagreement on approach in a first End-to-End R NDA submission, coordinating sequential readouts within a tight timeline on the same molecule, and adapting to mid-stream regulatory changes during a peak-paced pivotal molecule — and reveals the influencing techniques that transformed potential roadblocks into strategic wins. Underlying each case are five core moves: understand stakeholder concerns, offer concrete mitigation, create protective mechanisms, maintain transparency, and establish clear accountability.
Power Players: Statisticians as Strategic Drug Developers
We believe that statisticians should play a broader role in drug development, beyond our traditional roles and deliverables, by bringing our rigorous and unbiased perspective to strategic decision-making under uncertainty. This requires a deep understanding of both the development strategy and the cross-functional implications, and statisticians need to build leadership skills in relationships, active listening, and influencing. We will share our personal experiences and perspectives about how statisticians in biopharma can reach our ultimate potential.
