Job Description
📋 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
