Steven Ullery has over 30 years of experience as a biostatistician working in medical research. He is an expert in study design and analysis and has worked on various types of studies including preclinical, retrospective, randomized, observational, and post-market. In the 9 years he has worked for NAMSA, Steven has guided many clients, both large and small, through the development and execution of clinical trials used for business and regulatory needs. Steven has worked with regulatory bodies both domestic and foreign, including the regulatory agencies in Europe, Japan, and China.
He has supported research in a variety of therapeutic and diagnostic areas including Neuro, Cardio, and Peripheral vascular devices. Steven’s primary focus is on study design, including sample size estimation, interim analysis, and methods of analysis, including meta-analysis and general linear mixed models.
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
- 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 studies
- Working with Data Safety Monitoring Boards (DSMBs)
- Reviewing PMAs prior to submission
- Providing statistical analysis for posters to be used in marketing and at technical meetings
RECENT PROJECTS
- Designed a trial comparing a device for treating amblyopia to patching. This was a randomized trial with an interim analysis after 75% of the subjects completed the primary endpoint and a blinded sample size re-estimation after 50% of the subjects completed the primary endpoint.
- Designed a single-arm trial to study a new wearable cardiac defibrillator. Performance goals for the endpoint of inappropriate shock were derived from the current literature. Given the primary endpoint of estimating the inappropriate shock rate, sample size and power were estimated using simulations. An interim analysis was also added to this design.
- Designed preclinical GLP studies that compared a test article to a control article for non-inferiority and/or superiority. The analysis commonly used bootstrapping methods to assess the primary endpoints.
PUBLICATIONS
- Kohli DR, Mettman D, Andraws N, Haer E, Porter J, Ulusurac O, Ullery S, Desai M, Siddiqui MS, Sharma P. Comparative accuracy of endosonographic shear wave elastography and transcutaneous liver stiffness measurement: a pilot study. Gastrointest Endosc. 2023 Jan;97(1):35-41.e1. doi: 10.1016/j.gie.2022.08.035. Epub 2022 Aug 29. PMID: 36049537.