Serve as a lead statistician on clinical studies and provide senior level statistical input to BDM department. Maintain the statistical and analytical integrity of clinical trials data analyzed by in-house resources or external vendors. Actively participate in writing statistical sections of protocols, preparing statistical analysis plans.
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 or executive-levels. 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. Plays a statistical leadership role in the support of Regulatory filings and submissions. Contributes to the development of charters for DSMBs and Endpoint Adjudication Committees and may serve as a sponsor liaison with these committees. Manages the development, review and approval of relevant SOPs, and CRF design. Ensures adequate procedures and processes are in place for the biostatistics group and that data set and analyses are stored according to established company policies and all relevant regulatory mandates. Prepares and provides written reports, presentations and publications as required. Collaborates with other functional lines including Regulatory, Clinical Sciences and Clinical Operations. Serves as point of contact for biostatistical support and data management services provided by external vendor. Identifies, develops and delivers internal biostatistics training courses as required. Manages the utilization of resources and identifies when and where additional resources may be needed to provide effective biostatistics support to customers. Responsible for providing regular performance feedback, development and coaching to direct reports.