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)
• Electromagnetic breast and lymph node markers which tag lesions to be removed.
• Devices that stop postpartum hemorrhage.