Statistician Leader

The Lead Biostatistician plays a pivotal leadership role in developing, implementing and overseeing statistical strategies for clinical trials. Reporting to the Head of Biostatistics, this position drives the planning, execution and interpretation of statistical analyses across development programs.

• Develop biostatistical strategies on assigned studies and projects
• Collaborate on study design discussions, including protocol development, endpoint definition and sample size estimation
• Review and approve Statistical Analysis Plans (SAPs), featuring mock tables, figures and listings
• Oversee statistical analysis execution in conjunction with programming and CRO partners
• Provide statistical guidance in vendor oversight, directing programming activities and managing deliverables
• Communicate project status to management and escalate issues or risks in a timely manner
• Contribute statistical expertise to clinical study reports, regulatory documents and publications
• Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards
• Present statistical findings to internal and external stakeholders, or regulatory authorities as needed

• Master's degree or PhD in Biostatistics, Statistics or related quantitative field required
• Minimum 8 years' experience in clinical trial biostatistics for MS-level candidates; minimum 6 years for PhD-level candidates
• Proficiency in SAS programming; R and other programming languages preferred
• Strong understanding of statistical methodologies and clinical trial designs
• Experience with CDISC standards (e.g., SDTM, ADaM) and their application
• Proven ability to manage multiple studies and timelines concurrently