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.