Principal Statistician Oncology with Submission Experience

Tasks

• Attend DSMB activities
• Conduct independent review
• Conduct verification and quality control
• Contribute to proposals and budgets
• Create mock ups tables listings figures
• Create programming specifications
• Direct biostatistics activities
• Ensure protocol criteria met
• Generate randomization schedule
• Implement statistical objectives
• Input for clinical study report
• Interface with project team representatives
• Lead statistical aspects of protocols
• Maintain project documentation
• Mentor biostatisticians
• Oversee biostatistics training plans
• Prepare statistical analysis plans
• Provide statistical programming support
• Review annotated case report forms
• Review database design
• Support Data Monitoring Committee activities
• Support regulatory agency meetings
• Support sponsor bid defenses
• Support submissions and integrated analyses

Perks/Benefits

• Career development
• Inclusive culture
• Peer recognition
• Total rewards program
• Training and technical education

Skills/Tech-stack

Analysis Plan | Biostatistics | CRF review | Clinical study | Clinical study report | Clinical trial | Database Design | ICH Guidelines | Integrated Analysis | Protocol development | Quality Assurance | Quality Control | Randomization | Regulatory Submissions | SAS | SAS programming | Statistical Analysis | Statistical Analysis Plan | Statistical programming