Senior Principal Biostatistician _Biopharma

Tasks

• Assess available data for business development
• Co author clinical study reports
• Critically review statistical interpretation
• Develop Integrated Analysis Plan
• Develop clinical trial study design
• Develop integrated safety and efficacy summaries
• Develop protocol and CRF
• Estimate sample size
• Lead Japan regulatory filings
• Oversee CRO for statistical deliverables
• Oversee patient randomization
• Perform quality oversight of statistical deliveries
• Perform statistical analyses
• Provide statistical expertise for compound development scenarios
• Provide statistical support for regulatory submissions
• Respond to regulatory agency requests
• Review statistical methods sections for clinical study reports
• Support Japan marketing authorization activities
• Support Japan specific programming tasks
• Support interactions with Japanese health authorities and KOLs
• Support manuscripts and manuscript review
• Support process improvement using lean
• Write Statistical Analysis Plans

Perks/Benefits

• N/A

Skills/Tech-stack

Biostatistics Quality Documents | CRO oversight | Clinical study | Clinical study report | Data reporting | Data reporting standards | GCP | ICH | Integrated Analysis | Lean | Patient randomization | Quality Documents | R | Regulatory Submissions | Reporting standards | SAS | Sample Size | Sample size estimation | Size estimation | Statistical Analysis | Study design