Lead Clinical Data Analyst

Senior Biostatistician Job Summary

As a Senior Biostatistician, you will lead the planning, execution, and interpretation of statistical analyses in support of clinical trials. You will contribute to high-quality deliverables that meet regulatory and scientific standards.

• Biostatistics leader for assigned studies and projects
• Study design discussions, protocol development, endpoint definition, sample size estimation
• Statistical Analysis Plans (SAPs), including mock tables, figures, and listings (TFLs)
• Execution of statistical analyses per SAP with programming and CRO partners
• Statistical leadership in vendor oversight, directing statistical programming activities and managing deliverables
• Communication of project status to management, escalating issues or risks
• Statistical input and review for clinical study reports, regulatory documents, and publications
• Quality control (QC) of statistical outputs for accuracy and compliance
• Statistical presentations to internal and external stakeholders, or regulatory authorities
• Development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs) and internal guidelines

Requirements :

Bachelor's degree or higher in Biostatistics, Statistics, or related quantitative field , 10 years of experience in clinical trial biostatistics, proficiency in SAS, knowledge of R and other programming languages.