PHILADELPHIA, July 10 /PRNewswire/ -- Premier Research Group plc (AIM: PRG), the international pharmaceutical services group, announces the appointment of David A. Fitts, MPH, Ph.D. as Executive Director, Biostatistics. In this position, Dr. Fitts will be responsible for the operations, strategic planning, management oversight, and development of all biostatistics and programming functions in the United States
Tara Fitzgerald, MS, Vice President, Biometrics, said, “We are very excited to have someone with David’s vast experience and proven track record join Premier Research. As an organization, we have grown significantly and have established a need for someone of David’s caliber to lead our biostatistics efforts and serve as a valuable asset to our increasing client base.”
Dr. Fitts brings an extensive background in Biostatistics and Data Management with more than twenty years experience in the pharmaceutical industry. Most recently, he was Vice President, Global Biostatistics and Data Sciences at EMD Pharmaceuticals within the Clinical R&D Organization of Merck KGaA. There he managed a global staff of 42 and was responsible for providing biostatistical, programming, and data management support to Merck’s clinical development portfolio. In addition, he participated in strategic and tactical decision-making on Merck’s operational and scientific management teams.
Originally trained as Pharmacist, Dr. Fitts earned his Master of Public Health (Epidemiology) and Ph.D. (Biostatistics) degrees at Tulane University. In 1998, he joined SmithKline Beecham as a project biostatistician, ultimately becoming Associate Director of the Biometrics Oncology team. At SmithKline Beecham, he gained experience in US and European regulatory processes while supporting three successful NDAs and by defending the application for topotecan at multiple ODAC and EMEA hearings.
Additionally, Dr. Fitts has a strong record of professional development. He has presented on such diverse topics as Non-Inferiority Designs, Efficiency in Clinical Development, Preparation of Statistical Analysis Plans, and Creation of an Integrated Data Warehouse. Dr. Fitts is a reviewer for the Journal of Clinical Oncology and is a member of the board of directors for Axum Pharmaceuticals, a biotechnology company focused on the development of therapeutic vaccines.
About Premier Research
Premier Research is a leading solutions-driven CRO leveraging our commitment to therapeutic focus and scientific expertise to deliver services of the highest quality for Phase I-IV clinical trials. Premier Research is a leader in clinical research for Analgesia, CNS, Infectious Disease and Oncology and has a wealth of experience in pediatric research.
Premier Research has 28 offices and operates in more than 30 countries across Europe and North America. Premier Research employs more than 750 clinical professionals dedicated first and foremost to fulfilling each client’s requirements in a timely, accurate and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific and medical experts, and staff at our well-established network of dedicated clinical sites.
Premier Research
CONTACT: Dr. Simon Yaxley, Chief Executive Officer of Premier ResearchGroup plc, +44(0)118 965 4082; or Lisa Baderoon/Rebecca Skye Dietrich ofBuchanan Communications for Premier Research, +44(0)20 7466 5000