Principal Biostatistician

Tasks

• Analyze clinical data
• Create review oversee statistical output
• Design clinical studies
• Develop and review Statistical Analysis Plans
• Develop and review protocols
• Interpret clinical study results
• Lead biostatistics activities for studies
• Maintain oversight of contracted statistical deliverables
• Mentor junior biostatisticians
• Plan coordinate and report statistical analyses
• Present findings in meetings
• Provide statistical programming oversight
• Provide statistical specifications and guidance
• Review ADaM datasets
• Review ADaM specifications
• Review SDTM datasets
• Review SDTM specifications
• Review TLFs
• Review summary report sections
• Stay current on clinical trial statistics best practices
• Support audits and bid defenses

Perks/Benefits

• N/A

Skills/Tech-stack

ADaM | Analysis Plan | BLA | Biostatistics | Clinical Protocol | Clinical Protocol Development | Clinical trials | Data Safety | Data Safety Review | ICH | ICH E6 | ICH E6 R2 | IDE | IND | Logistic Regression | Medical writing | Mixed Models | Mixed-effects | Mixed-effects models | NDA | PMA | Protocol development | Regulatory Submissions | SAS | SDTM | Safety review | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Summary Reports | Survival analysis