Clinical Research

• Provide scientifically rigorous statistical input on post-hoc and ad-hoc analysis requests to support publication projects and regulatory query responses.
• Develop statistical analysis plans, mock-up tables, and quality check plans.
• Oversee programming support activities for assigned projects and validate the accuracy, consistency, and integrity of statistical output displays generated by programmers.
• Lead multiple project teams using project management skills and statistical/programming techniques to prepare, execute, report, and document high-quality statistical analyses.
• Conduct peer reviews of project-related work performed by other statisticians, ensure compliance with regulatory requirements, and maintain project documentation and files.
• Communicate effectively and independently with the client to coordinate statistical and programming aspects of the project.
• Demonstrate a strong understanding of ICH guidelines and clinical trial design as applicable to statistics.

Principal Biostatistician

Clinical Trial Manager

Senior Clinical Trial Manager

Clinical Trial Manager, Early Oncology

Principal Biostatistician, Medical Affairs