Dedicated and highly motivated professional with medical training and comprehensive knowledge of applied statistics, medical affairs, regulatory policies, clinical medicine, and biomedical research; and more than ten years of experience in drug and medical device development with in-depth knowledge of clinical trial operations, FDA regulations on the approval of drug-eluting stents, Endovascular Aneurysm Repair device, Vascular Closure device, and stents for various endovascular indications. Strong track record of leading statistical operations in a global matrix environment, resulting in successful filing and FDA approval for multiple device pre-market approval (PMA) in US and CE mark approval in the European Union.Specialties: Clinical trial design, statistical analysis and reporting,