Principal Biostatistician Medical Affairs

Tasks

• Contribute to protocol design and randomization schedules
• Coordinate biostatistics and programming activities
• Develop and review Statistical Analysis Plans
• Develop proposals and budgets for business development
• Mentor junior biostatistics team members
• Perform quality control of statistical outputs
• Provide statistical support across clinical study phases
• Review programming specifications and statistical outputs
• Serve as statistical representative on cross functional teams
• Support regulatory submissions and committee activities
• Track study timelines and manage project milestones
• Validate case report forms and database structures

Perks/Benefits

• Fully remote
• International working environment
• Professional development

Skills/Tech-stack

Analysis Plan | Case Report Forms | Clinical Data Quality | Clinical Trial Design | Clinical data | Clinical study | Clinical study report | Clinical trial | Data Quality | Data Validation | ICH Guidelines | Programming specifications | Randomization | SAS | Statistical Analysis | Statistical Analysis Plan | Statistical methodology | Table Listing Figure | Trial design