The shift in the drug development process to the “Learn & Confirm” paradigm has highlighted important challenges and gaps in the “Learn” stage of the clinical development process. This presentation focuses on the key role Statistics needs to play in several areas to help create an effective “Learn” environment. These include: 1) Education and training of the cross-functional organization (Medical Research, Project Management, Regulatory, Statistics, Governance groups) to help transform the approach to decision making based upon the appropriate criteria; 2) Building technical expertise in modeling, simulation, innovative and optimal designs, coupled with enhanced consulting skills; 3) Development of the required computational tools to facilitate broad implementation of the appropriate design, analysis and decision making approaches.