Principal Biostatistician - Sponsor dedicated - France

Tasks

• Attend regulatory agency meetings
• Coach and mentor biostatistics staff
• Conduct verification and quality control of deliverables
• Coordinate biostatistics and statistical programming personnel activities
• Create or review programming specifications
• Develop mock up displays for tables listings figures
• Develop randomization schedule
• Ensure deliverables match SAP and specifications
• Identify out of scope tasks and escalate
• Maintain project documentation and inspection readiness
• Manage scheduling and workload across projects
• Monitor study progress against milestones
• Participate in data monitoring committee activities
• Participate in data safety monitoring board activities
• Prepare statistical analysis plans
• Provide statistical programming support
• Provide support for statistical tasks across clinical trial lifecycle
• Review SAS annotated case report forms
• Review database design and study documentation
• Serve as biostatistics representative on project teams
• Support integrated analyses
• Support proposal and budgeting activities
• Support protocol statistical aspects

Perks/Benefits

• Career development
• Inclusive culture
• Peer recognition
• Technical training
• Therapeutic area training
• Total rewards program

Skills/Tech-stack

Analysis Plan | Biostatistics | Case Report Forms | Clinical study | Clinical study report | Clinical trials | Data Quality | ICH Guidelines | Quality Control | Randomization Schedule | Randomized Trial | SAS | SOPs | Statistical Analysis | Statistical Analysis Plan | Statistical programming