Principal Biostatistician/Senior Principal Biostatistician

📋 Description

• Consult with clients on trial design and regulatory strategy
• Develop and review statistical methods for study protocols
• Provide and/or verify sample size calculations
• Author and review statistical analysis plans for complex study designs
• Review statistical outputs to ensure accuracy
• Provide statistical analysis to DMCs as unblinded biostatistician

🎯 Requirements

• Master's or PhD in Statistics/Biostatistics with 9+ years (PhD) or 12+ years (MS)
• Principal level: Master's with 10+ years or PhD with 7+ years
• Broad experience with regulatory submissions
• Extensive client-facing experience in trial design and regulatory strategy
• Strong knowledge of Bayesian adaptive design and survival analysis
• Experience with SAS and ICH/CDISC, 21 CFR Part 11, FDA guidelines

🎁 Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation