Principal Biostatistician

Tasks

• Contribute to proposals and bid defenses
• Coordinate statistical analyses for regulatory submissions
• Design clinical studies
• Develop and review protocol statistical sections
• Develop and review statistical analysis plan
• Interpret clinical study results
• Lead biostatistics activities for clinical studies
• Maintain compliance with ICH and regulatory requirements
• Mentor and support junior biostatisticians
• Oversee creation and review of statistical outputs
• Perform statistical analysis
• Provide quality review of statistical outputs
• Provide specifications for statistical outputs
• Represent biostatistics in meetings and audits
• Review and provide feedback on statistical documents
• Support project timelines and financial tracking
• Support trial design and consult on complex methods

Perks/Benefits

• N/A

Skills/Tech-stack

Analysis Plan | Biostatistics | Clinical Study Design | Clinical study | Clinical trials | Data Safety | Data Safety Review | ICH Guidelines | Logistic Regression | MS Office | MS Office Suite | Mixed Models | Office Suite | Regulatory Submissions | SAS | Safety review | Statistical Analysis | Statistical Analysis Plan | Study design | Survival analysis