Principal Biostatistician

Tasks

• Analyze clinical study data
• Conduct statistical programming oversight
• Design clinical studies
• Develop statistical analysis plan
• Develop statistical programming specifications
• Ensure work quality and validity
• Interpret clinical study results
• Lead biostatistics activities
• Maintain statistical documents
• Manage study timelines and financials
• Mentor junior biostatisticians
• Oversee statistical output
• Provide departmental training
• Provide statistical guidance for pivotal outputs
• Represent biostatistics in meetings and audits
• Review ADaM datasets
• Review SDTM datasets
• Review TLFs
• Review clinical protocol sections
• Review clinical study reports
• Support IDE PMA submissions
• Support IND NDA BLA submissions
• Support clinical trial design
• Support data safety review meetings
• Write final CSR summaries
• Write interim analysis summaries

Perks/Benefits

• Remote work
• Work-life balance

Skills/Tech-stack

ADaM | Analysis Plan | Clinical protocols | Clinical study | Clinical study reports | Clinical trials | Data Safety | Data Safety Review | ICH Guidelines | Logistic Regression | Mixed Models | SAS | SDTM | Safety review | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Study Reports | Survival analysis