Clinical Research

• Lead complex studies such as New Drug Applications submissions or complex, multi-protocol programs
• Perform project management activities for identified projects including resource planning, timelines and milestone management
• Serve as Data Monitoring Committee Support Statistician
• Lead the development of complex Statistical Analysis Plans
• Conduct overall statistical review of Tables, Figures and Listings for complex studies prior to client delivery
• Review Case Report Form and other study specific specifications and plans
• Develop the statistical sections of the protocol for complex studies
• Preparation and review of randomization specifications and generation of randomization schedules
• Provide mentoring and training to less experienced staff
• Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences
• Attend bid defense meetings for complex studies
• Act as Subject Matter Expert and develop or review procedural documents
• Represent the department during audits.

Principal Biostatistician – FSP

Director of Strategy – Business Operations, Healthcare, Clinical Research

Channel Manager, Clinical Research Organizations

Principal Biostatistician – RWE Specialist

Clinical Trial Manager, Phase 3

Clinical Scientist