• Guides Product Strategy and Study Design • Promotes innovative design options and fit-for-purpose analysis approaches that address appropriate clinical questions in protocol / program design and balance speed, quality, and cost • Provides advisory input in the development of the Global Statistical Strategic Plan (GSSP) to align study design and statistical approaches with product strategy and Evidence Generation Plan (EGP) • Reviews key phase 2 and 3 protocols and provides input during the TA TRC review • Provides technical expertise to GSL and EGT on innovative study designs and advanced analytical methods • Provides design options and simulation specifications to the Simulation and Modeling team and develops and approves the simulation plan and results • Interprets and communicates modeling and simulation results to inform and guide the selection of optimal trial designs • Provides guidance and training to the Simulation and Modeling biostatisticians • Develops positive relationships with SDDs, GSLs and the Modeling and Simulation team to ensure a CfDA ‘team’ approach when interacting with product teams • Establishes relationships with TA TRC members to ensure alignment in development strategies • Promotes the advancement of innovative designs and analysis methods • Builds professional network with external peers in innovative designs and analysis methods • Promotes awareness of innovative designs and analysis methods by coordinating and providing internal training sessions