Nicole C. Close, Ph.D., Founder of EmpiriStat

Dr. Close is trained in Epidemiology and Biostatistics and has more than 15 years of professional experience conducting and managing clinical trials and epidemiological research, including the management of coordinating centers and large-scale, multi-site data collection and statistical analysis activities. Her passion for her field is expressed in the diligence and insightfulness she brings to each project and therapeutic area.

Her diverse background provides a solid foundation for EmpiriStat’s Corporate knowledge, supplemented by a team of highly trained colleagues in complementing areas of expertise.

Regulatory Background

Dr. Close’s Unit, at a previous position, supported 23 open INDs, including pre-clinical and clinical Phase I- III studies and epidemiological surveillance studies in various infectious disease and vaccine development areas. Dr. Close prepared documents and attended briefings with the highest ranking officials, FDA regulatory meetings and teleconferences, and for pharmaceutical partner New Drug Application (NDA) teams. Her therapeutic experience extended in infectious diseases and vaccine development including HIV, Dengue, Malaria, Small Pox, Chikungunya, Leishmaniasis, Haantan, Group B meningococcal, shigella and she has also worked on repellant studies for camouflage face paint.

The Collaborative Islet Transplant Registry

Recently, Dr. Close served as the Principal Investigator of the Statistical Analysis Coordinating Center for the Collaborative Islet Transplant Registry, the largest and most comprehensive database of islet transplant recipients in the world. This initiative is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Juvenile Diabetes Research Foundation International. Dr. Close not only provided scientific and statistical guidance for the development and maintenance of this Registry, but she served as a member of its executive committee and as a member of the scientific advisory committee.

Dr. Close's accomplishments included:

directed the overall design of the registry, materials and data collection instruments
developed and implemented clinical monitoring and quality assurance mechanisms
all statistical analyses and annual report production
manuscript writing, interpretation of results and presentation of the yearly data

During her leadership role, Dr. Close summarized data for the first Biologics License Application (BLA) in pancreatic islets and helped and assembled the Investigator's Brochure (IB).

Other Therapeutic Areas

Dr. Close has a distinct background. In addition to the areas described above, she has led and participated on studies in vocal therapy, US childhood immunizations assessment and strategies, hypertension in minority populations, peripheral vascular disease, dental caries transmission, emergency medicine protocols, ophthalmology, rabies and Legionnaire's disease.

Additional Qualifications and Interests

Dr. Close is an active member, Committee member and Workshop faculty member for a number of professional organizations including the American Statistical Association, The Society for Clinical Trials, and the International Society for Clinical Biostatistics. She is trained in the Clinical Data Interchange Standards Consortium (CDSIC) Submission Data Standards (SDS), Operational Data Model (ODM), Analysis Data Model (ADaM) and the Laboratory Standards (LAB), and is experienced in NQuery, WinNonLin, EquivPK, PASS, and SAS (Base, Stat, Graph, IML, ACCESS, GIS, ETS, FSP).