Directs the design, development, modification and evaluation of a technical infrastructure to expedite the operation and evaluation of clinical trials. Serve as a lead statistician on clinical studies and provide senior level statistical input. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules, and performance requirements are met. Regularly interacts with senior management. Communicates with various internal and external audiences such as, scientists, engineers, clinicians, quality staff and partners as required. Provides strategic input on protocol design and clinical trial data analysis, develops statistical analysis plans and statistical methodology sections of planned protocols, oversight of programming support and of any outsourced biometric responsibilities. Provides a statistical interface with Regulators, crafting responses to relevant Regulatory questions, providing assistance in the generation of high-quality clinical trial data to aid in programmatic decision-making.