Statistical Consulting


Dr. Johnson offers expert guidance to pharmaceutical companies in planning clinical trials and preparing clinical development programs, with the goal of rapid approval by regulatory authorities. She has prepared concise and persuasive regulatory correspondence and briefing books, and has participated in numerous meetings with the FDA during which key statistical arguments led to favorable regulatory decisions.


Statistical Services
 

Dr. Johnson offers a comprehensive range of biostatistical services, including:


  • Statistical input into study protocols and clinical development plans
  • Sample size requirements (individual studies or full development programs)
  • Review and interpretation of statistical output in SAS
  • Preparation and/or review of:
    • Statistical analysis plans
    • Clinical study reports
    • New drug applications
    • Regulatory summary documents
      • Integrated Summary of Efficacy (ISE)
      • Integrated Summary of Safety (ISS)
    • Responses to FDA/EMEA questions and action letters
    • SOPs for regulatory-compliant statistical operations
  • Participation in:
    • Data Safety Monitoring Boards (DSMBs)
    • Scientific advisory groups
    • Mock FDA advisory panels