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Senior Biostatistics Expert

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Biostatistician Leadership Opportunity

  • We are seeking an experienced Biostatistician to lead our statistical strategies and deliverables in support of clinical trials.

This role contributes to the planning, execution, and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.

Key Responsibilities:
  • Study Design and Execution
    • Serve as biostatistics leader for assigned studies and projects
    • Lead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation
  • Statistical Analysis Planning
    • Author and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings (TFLs)
  • Clinical Study Reports and Regulatory Documents
    • 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
  • Quality Control and Assurance
    • Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards
  • Regulatory Interactions and Compliance
    • Lead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations

Requirements:

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