Go to Client Portal

Steven Ullery, MS

Principal Product Development Strategist - Statistics

Reserve your Consultation with our Experts

Contact Us

Steven Ullery is responsible for providing support and consulting in the area of biostatistics at NAMSA. He has supported numerous regulatory submissions, manuscripts, presentations, marketing materials and other publications with a focus on statistics and scientific considerations. Steven is a Biostatistician by training, holding a Master Degree in Statistics from the University of California, Riverside.


  • Responding to the U.S. Food and Drug Administration (FDA), Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada and other regulatory body questions for various clinical projects
  • Guiding clinical trials to a successful conclusion and subsequent submission to the FDA
  • Team presentations to the FDA and preparing formal responses and submissions
  • Answering questions regarding protocol and statistical analysis plans and presenting proposed analyses directly to the FDA
  • Providing support to numerous medical affairs activities, including:
    • Protocol review for investigator initiated studies (China, Japan, EU)
    • Working directly with physicians on manuscripts
    • Participating in planning post-market trials for additional indications
    • Providing statistical support to international partners
  • Statistical support for preclinical, quality and research and development (R&D)
  • Reviewing PMAs prior to submission
  • Working with Data Safety Monitoring Boards (DSMBs)
  • Providing statistical analysis for posters to be used in marketing and at technical meetings


  • Neurology, cardiovascular and peripheral vascular devices (e.g. stent, grafts, and aneurysm coils)
  • Implantable hearing aids for adult and pediatric populations
  • Knee, hip and shoulder replacements
  • Ophthalmology (color vision testing, contrast sensitivity testing, eye measurement devices)
  • Electromagnetic breast and lymph node markers which tag lesions to be removed.
  • Devices that stop postpartum hemorrhage.