Chief Statistician

Biostatistician Role

The Senior Biostatistician plays a key role in advancing the Client's R&D sponsored clinical trials through strategic statistical leadership and expertise.

• Lead biostatistics initiatives for assigned studies and projects
• Contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation
• Develop and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings
• Oversight 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
• 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
• Support regulatory interactions on statistical issues and provide applicable statistical strategies
• Deliver statistical presentations to internal and external stakeholders

• Masters degree or PhD in Biostatistics, Statistics, or related quantitative field
• Minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum 6 years for PhD-level candidates
• Proficiency in statistical programming in SAS. Knowledge of R and other programming languages preferred
• Solid knowledge of statistical methodologies and clinical trial designs
• Strong understanding of CDISC standards (e.g., SDTM, ADaM) and their application
• Experience with regulatory support and interaction