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Steven Ullery, MS

Principal Product Development Strategist - Statistics

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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.

CORE COMPETENCIES

  • 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

RECENT PROJECTS

  • 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)