Executive Statistician

Senior Biostatistician Position Summary

The Senior Biostatistician is a critical team member who leads the development, implementation and oversight of statistical strategies and deliverables in support of clinical trials. This role contributes to planning, execution, and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.

• Lead or contribute to study design discussions including protocol development, endpoint definition, and sample size estimation
• Author and review Statistical Analysis Plans (SAPs) including mock tables, figures, and listings (TFLs)
• Oversee execution of statistical analyses per SAP in collaboration with programming and CRO partners
• Provide statistical leadership in vendor oversight including directing statistical programming activities and managing deliverables
• Regularly communicate project status to management and escalate issues or risks in a timely manner
• Provide statistical input and review for clinical study reports, regulatory documents, and publications
• Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards
• Lead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations
• Deliver statistical presentations to internal and external stakeholders as needed
• Contribute to development, review, and maintenance of statistical standard operating procedures (SOPs), working instructions (WIs), and internal guidelines
• Good knowledge of CDISC standards including SDTM, ADaM
• Stay current with emerging statistical methodologies and evolving clinical trial practices
• Perform other duties/tasks as required or assigned