Principal Biostatistician Medical Affairs

Tasks

• Conduct quality control for statistical outputs
• Contribute to protocol design and randomization schedules
• Create mock tables figures listings
• Develop and review Statistical Analysis Plans
• Develop regulatory statistical documentation
• Mentor junior biostatisticians
• Oversee biostatistics and programming deliverables
• Provide statistical support across clinical trial phases
• Review programming specifications and outputs
• Support regulatory submissions and advisory board activities
• Track study timelines and deliver milestones
• Validate case report forms and database structures

Perks/Benefits

• Advanced Data and Technology Access
• Career progression
• International collaboration
• Professional development
• Remote work

Skills/Tech-stack

Analysis Plan | Case Report Form | Clinical Trial Design | Clinical study | Clinical study report | Clinical trial | Data Quality | Data quality assurance | ICH Guidelines | Programming specifications | Quality Assurance | Randomization | SAS | Statistical Analysis | Statistical Analysis Plan | Statistical Methodologies | Statistical programming | Trial design