Principal Biostatistician

Tasks

• Analyze clinical study data
• Conduct statistical analyses for regulatory submissions
• Design clinical studies
• Develop summary report findings
• Ensure statistical content quality and validity
• Ensure work is completed on time
• Interpret clinical study results
• Lead biostatistics activities for studies
• Maintain and oversee statistical outputs
• Oversee statistical programming activities
• Provide guidance to clinical teams
• Provide mentoring for junior statisticians
• Provide specifications for statistical outputs
• Represent Biostatistics in meetings
• Review ADaM datasets
• Review ADaM specifications
• Review SDTM datasets
• Review SDTM specifications
• Review TLFs
• Review and develop clinical protocols
• Support IDE PMA submissions
• Support IND NDA BLA submissions
• Support audits and bid defenses
• Write or review statistical analysis plans

Perks/Benefits

• Career development
• Cross-functional collaboration
• Remote work
• Work-life balance

Skills/Tech-stack

ADaM | Analysis Plan | Clinical Protocol | Clinical Trial Design | Clinical trial | Data Quality | ICH | Logistic Regression | MS Office | Mixed Models | Regulatory Submissions | SAS | SDTM | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Summary Report | Survival analysis | Trial design