R -- Biostatistics

This is a notice of intent, not a request for a proposal. A solicitation document will not be issued and proposals will not be requested. The National Institute on Drug Abuse (NIDA), Station Support/Simplified Acquisition (SS/SA) Branch intends to negotiate and award a purchase order on a noncompetitive basis to Dr. James Dambrosia to provide statistical reviews and critique clinical protocols to be implemented within NIH. Such work will include evaluation of the adequacy of the statistical design to provide an inferential basis to test the hypotheses associated with the proposed research question(s) with appropriate power and error probabilities. Dr. Dambrosia will provide expert statistical consultation and collaboration to Clinical Neuroscience Program (CNP) clinical neuroscience researchers on data analysis, modeling, and inferential interpretation of CNP studies; collaborate with the clinical researchers in the preparation and drafting of manuscripts for publication of the scientific findings in peer-reviewed journals; work with the clinical researchers to respond in writing to questions and comments regarding statistical issues raised by journal referees; and participate as a as statistical reviewer of submitted clinical protocols. In addition, he will provide CNP clinical neuroscience researchers with statistical planning and design expertise in the development of CNP clinical protocols. This includes translation of clinical questions into testable statistical hypotheses with clearly defined and measurable responses and outcomes; recommend appropriate statistical methods for the analysis of the study data and provide power analyses to ensure that the study sample size is sufficient to detect meaningful clinical differences in comparative studies. Dr. Dambrosia has more than 30 years of experience in the statistical planning, design, data analysis, and implementations of study protocols in clinical neuroscience research at the NIH; is currently involved in the statistical analysis and modeling of data from several neurological research studies; worked on data from a wide range of neurological diseases and has an understanding of the statistical issues involved in analyzing, modeling, and interpreting such data and has provided expert statistical review and consultation on various protocols. It is essential that CNP have a high level of biostatistical expertise with experience and involvement in all aspects of clinical neuroscience research. This service is required for both the continuation and completion of ongoing clinical research, Protocol 02-N-0142, A Comparison of Contrast-Enhanced Magnetic Resonance Angiography Using a Head and Neck Coil with Conventional Angiography for the Diagnosis of Vascular Disease from the Aortic Arch through the Circle of Willis and for the development of new research protocols in the CNP. CNP requires expertise and experience in the statistical design and evaluation of clinical neuroscience research protocols; statistical analysis and modeling of data from longitudinal natural history studies, case-control studies, and therapeutic clinical trials associated with neurological diseases; statistical consultation and collaboration on analytic aspects of design, analysis, and statistical interpretation of ongoing and completed clinical neuroscience research studies and statistical review and revisions of the experimental designs of clinical research protocols. Selection of another source could cause unacceptable delays in fulfilling the agency's requirement (FAR 6.302-1 (B)). The Government intends to select the offer that represents the best value to the Government, price and all other factors considered. This acquisition is being conducted under FAR Part 13, Simplified Acquisitions. This notice of intent is not a request for competitive quotes. Interested parties may identify their interest and capabilities in response to this synopsis. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely with the discretion of the Government.