Principal Statistician Oncology with Submission Experience

Tasks

• Attend regulatory agency meetings
• Create analysis programming specifications
• Develop mockup displays
• Direct biostatistics activities
• Ensure protocol criteria met
• Generate randomization schedule
• Implement study documentation and quality control
• Input for clinical study report
• Lead complex submissions
• Manage project scheduling and timelines
• Mentor biostatisticians
• Monitor milestones and study progress
• Oversee training plans
• Participate in DSMB activities
• Perform independent review
• Perform verification and quality control of deliverables
• Prepare statistical analysis plans
• Provide statistical programming support
• Respond to regulatory questions
• Review SASR annotated case report forms
• Review database design
• Serve as lead biostatician for protocol statistical aspects
• Support statistical tasks across project lifecycle

Perks/Benefits

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

Skills/Tech-stack

Analysis Plans | Biostatistics | Case Report Forms | Clinical study | Clinical study report | Clinical trials | Database Design | ICH Guidelines | Programming specifications | Quality Assurance | Quality Control | Randomization | Regulatory Submissions | S&OP | SAS | SAS programming | Statistical Analysis | Statistical analysis plans | Statistical programming