Principal Biostatistician

Tasks

• Apply advanced statistical methods
• Assess regulatory requirements for therapeutic areas
• Contribute to integrated clinical reports
• Contribute to study design in meetings
• Deliver statistical training seminars
• Develop analysis plans
• Develop protocol and CRF
• Generate randomization lists
• Interact with clients and regulatory authorities
• Lead randomization production and quality control
• Perform sample size calculations
• Present study results
• Produce statistical reports
• Provide DMC review support
• Review clinical study reports
• Review position papers
• Support DMC charters and analysis plans
• Support bid defense meetings
• Support budget and proposal development
• Support trial design
• Train on statistical methods
• Write statistical methodology

Perks/Benefits

• Client exposure
• Independent work
• Mentorship opportunities
• Training seminars

Skills/Tech-stack

Analysis Plan | CRF development | Clinical Trial Design | Clinical trial | Data Monitoring | Data Monitoring Committee | GCP | ICH Guidelines | Integrated Clinical Reports | Protocol development | Randomization | SAS | Sample Size | Sample Size Calculation | Statistical Analysis | Trial design