Principal Biostatistician / Programmer

Tasks

• Contribute to proposals budgets and bid defenses
• Create and review programming specifications
• Develop mock up displays for tables listings figures
• Direct biostatistics personnel to ensure timely delivery
• Generate randomization schedule
• Lead biostatistics projects across multiple studies
• Lead or support regulatory submission statistical activities
• Maintain project documentation for inspection readiness
• Mentor biostatisticians and associates
• Oversee statistical training and onboarding
• Participate in DSMB and DMC activities
• Prepare statistical analysis plans
• Provide independent review of biostatistics work
• Provide programming support for analysis datasets
• Review SAS annotated case report forms
• Review database design and study documentation
• Serve as primary sponsor contact for biostatistics
• Support protocol statistical aspects
• Support statistical tasks from protocol to CSR
• Verify and conduct quality control of deliverables

Perks/Benefits

• Career development
• Peer recognition
• Technical training
• Therapeutic area training

Skills/Tech-stack

Analysis Plan | Biostatistics | Clinical study | Clinical study report | Clinical trials | Data Monitoring | Data Monitoring Committee | Data Safety | Data Safety Monitoring Board | Data safety monitoring | ICH | Protocol | Protocol development | Quality Control | Randomization | Regulatory Submissions | S&OP | SAS | Statistical Analysis | Statistical Analysis Plan | Statistical programming