Sr/Principal Statistician (Sponsor-dedicated) Many possible locations (EMEA) - Early Phase

Tasks

• Attend regulatory agency meetings
• Coach and mentor biostatistics staff
• Conduct verification and quality control of deliverables
• Contribute input to clinical study report
• Coordinate biostatistics and statistical programming activities
• Create or review programming specifications
• Develop mockup displays for tables listings figures
• Develop randomization schedule
• Ensure output matches SAP and specifications
• Escalate out of scope tasks
• Follow SOPs, WIs, and regulatory guidelines
• Lead integrated analysis projects
• Maintain project documentation for inspection readiness
• Manage scheduling and timelines across projects
• Monitor study progress against milestones
• Participate in data monitoring committee activities
• Participate in data safety monitoring board activities
• Perform independent review of biostatistics work
• Prepare statistical analysis plan
• Provide statistical programming support
• Review SAS annotated CRFs and study documentation
• Serve as biostatistics representative on project teams
• Support business development proposals and budgets
• Support statistical tasks across project lifecycle

Perks/Benefits

• Career development
• Inclusive culture
• Peer recognition
• Supportive line management
• Total rewards program
• Training and development

Skills/Tech-stack

Analysis Plan | Clinical trials | Data Monitoring | Data Monitoring Committee | Data Safety | Data Safety Monitoring Board | Data Visualization | Data safety monitoring | ICH | Quality Control | Randomization | Randomization Schedule | S&OP | SAS | Statistical Analysis | Statistical Analysis Plan | Statistical programming