NAMSA employs a highly experienced cadre of medical device-focused biostatisticians. Having come from Boston Scientific, Medtronic, United Health, Mayo Clinic, and 3M, our team members average over 15 years of experience in biostatistics. They work hand in hand with our clinical and data management groups to maximize efficiency.

Common Assignments

  • Statistical and analysis planning for clinical trial protocols
  • Study design: sample size calculations and power analysis
  • Randomization scheduling
  • Medical device data analysis and reports
  • Data monitoring committee and DMC support
  • Participation in FDA meetings and teleconferences focusing on statistical design or data analyses
  • Collaboration with medical device experts to extract meaningful clinical interpretations from data analyses for use in scientific papers or regulatory submissions
  • Statistical analysis and preparation of statistical sections for reports, including creation and validation of datasets, tables, and listings for clinical trials
  • Audits of project management, data management, and statistical groups
  • Report writing for regulatory submissions or other reporting requirements
  • Audit preparation and consulting support for FDA bioresearch monitoring (BIMO)