Senior/Principal Statistician Consultant

📋 Description

• Provide statistical leadership across clinical development programs, from early-phase studies
• Lead clinical trial design, including endpoint selection, sample size calculations, power analyses
• Develop and review clinical study protocols, statistical analysis plans (SAPs), and other
• Oversee statistical analyses and interpretation of clinical trial data to ensure scientific rigor
• Provide statistical expertise for regulatory submissions and interactions with health authorities
• Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs

🎯 Requirements

• PhD in Statistics, Biostatistics, or a related quantitative discipline; a Master's degree with
• Significant experience in biostatistics within the pharmaceutical, biotechnology, or clinical
• Strong knowledge of clinical trial design, statistical inference, sample size determination, power
• Proven experience developing and reviewing statistical analysis plans, clinical study protocols
• Familiarity with regulatory requirements and guidance applicable to clinical development and
• Experience supporting clinical development programs in oncology, rare diseases, and/or neuroscience.