Principal Statistician - Ophthalmology - Fully remote in Europe

Tasks

• Attend regulatory agency meetings
• Conduct quality control of deliverables
• Contribute to proposals and budgets
• Create or review programming specifications
• Develop mockups for tables listings figures
• Direct biostatistics personnel
• Ensure protocol criteria met
• Generate randomization schedule
• Interface with project team representatives
• Maintain project documentation for inspection readiness
• Mentor biostatisticians
• Oversee biostatistics training plans
• Participate in DMC activities
• Participate in DSMB activities
• Prepare statistical analysis plans
• Provide input to clinical study report
• Review SAS R annotated CRFs
• Review database design
• Review project work independently
• Support statistical programming as needed
• Support statistical tasks across protocol to CSR

Perks/Benefits

• Fully remote work

Skills/Tech-stack

Analysis Plan | Biostatistics | Clinical Research | Clinical study | Clinical study report | Clinical trials | Data Management | ICH | Protocol | Quality Control | R | Randomization Schedule | SAS | Statistical Analysis | Statistical Analysis Plan | Statistical programming