• Lead the development and execution of data management strategies for clinical trials involving medical devices. • Support the design of clinical studies and ensure accurate interpretation of clinical study data working cross functionally to ensure the needs of the business are met. • Lead the development and execution of statistical analysis plans for clinical studies. • Oversee the design and validation of clinical databases (e.g., EDC systems) and ensure alignment with study protocols and regulatory requirements. • Collaborate with cross-functional teams including Clinical Operations, Medical Affairs, Regulatory Affairs, and Quality Assurance. • Ensure high-quality data collection, cleaning, and reporting processes. • Manage data management and biostatistics vendors and CROs, ensuring deliverables are met on time and within budget. • Develop and maintain SOPs and best practices for biostatistics and data management activities. • Provide leadership and mentorship to data management and biostatistics staff. This role will have direct reports. • Performs other duties as required.