Director of Data and Biostatistics (Remote)

The Director of Data and Biostatistics will lead data operations for our Clinical Affairs team focused on medical devices. This role will be responsible for overseeing the design, implementation, and maintenance of clinical data systems, ensuring data integrity, and supporting regulatory compliance across all clinical studies.

Requirements

• 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.

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs