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Regulatory advisory firm/clinical research organization MCRA announced the formation and expansion of its biostatistical division, led by former FDA biostatistician Alvin Cutler Van Orden. To support the company’s growing role in providing biostatistical consulting services across all therapies, MCRA has hired Mr. Van Orden as its Vice President of Biostatistics.
Mr. Van Orden joined MCRA from FDA, where he spent over 15 years with the Center for Devices and Radiological Health, most recently as a Mathematical Statistician. Mr. Van Orden brings extensive experience to the role, including in-depth biostatistical reviews of submissions for orthopedic and other medical devices.
Prior to joining MCRA, Mr. Van Orden wrote statistical reviews of marketing submissions and provided feedback to medical device companies. Mr. Van Orden has a substantial background in utilizing an array of statistical tools and methods and has been involved at every stage of the FDA review process, from the planning stages to the analysis of clinical data and the design of post-market studies.
Glenn Stiegman, Senior Vice President of Clinical and Regulatory Affairs, said, “Mr. Van Orden’s extensive time at FDA has provided him with a deep understanding of what FDA will expect in a clinical study analysis, but also how to position it for success.”
Mr. Van Orden said, “I loved my time at FDA, and I see my work at MCRA as an extension of that role: to help life-improving medical devices get to market.”
Source: MCRA, LLC
