Principal Biostatistician Medical Affairs (Europe Only)

Tasks

• Attend regulatory agency meetings and respond to questions
• Coach and mentor biostatistics staff
• Conduct verification and quality control of deliverables
• Contribute to protocol statistical aspects
• Coordinate biostatistics programming personnel activities
• Create mockup displays for tables listings figures
• Develop randomization schedule
• Ensure deliverables align with SAP and specifications
• Escalate out of scope tasks to management
• Follow SOPs and regulatory guidelines
• Generate analysis datasets tables listings figures specifications
• Maintain inspection ready project documentation
• Manage scheduling across multiple projects
• Monitor milestones and study activity progress
• Participate in data monitoring committee activities
• Participate in data safety monitoring board activities
• Perform independent review of project work
• Prepare statistical analysis plans SAPs
• Review SAS annotated case report forms
• Review database design and study documentation
• Serve as biostatistics representative on project teams
• Support business development proposals and budgets
• Support integrated analyses
• Support statistical programming as needed
• Support statistical tasks across project lifecycle

Perks/Benefits

• N/A

Skills/Tech-stack

Analysis Plans | Clinical study | Clinical study report | Clinical trials | Data Monitoring | Data Monitoring Committee | Data Safety | Data Safety Monitoring Board | Data safety monitoring | ICH | Randomization Schedule | S&OP | SAS | Statistical Analysis | Statistical analysis plans | Statistical programming