Principal Biostatistician/Senior Principal Biostatistician

📋 Description

• Provide statistical leadership across clinical development phases
• Advise on study design and regulatory strategy with clients
• Develop and review statistical methods and sample size in protocols
• Write and review statistical analysis plans for complex studies
• Lead NDA/BLA/MAA submissions or multi-protocol programs
• Serve as SME in Bayesian adaptive design and survival analysis

🎯 Requirements

• Senior Principal Biostatistician: MS/PhD with 12+/9+ yrs
• Principal Biostatistician: MS/PhD with 10+/7+ yrs
• Broad experience with regulatory submissions
• Extensive client-facing study design/regulatory strategy work
• Proficient in Bayesian adaptive design, survival analysis, repeated measures
• SAS experience and CDISC/ICH/FDA guidelines familiarity

🎁 Benefits

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