MODIFICATION
R -- Biostatistician
- Notice Date
- 7/1/2014
- Notice Type
- Modification/Amendment
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA(SS-SA)-2014-CSS287
- Archive Date
- 7/26/2014
- Point of Contact
- Andrea McGee, Phone: 3014358781
- E-Mail Address
-
amcgee@nida.nih.gov
(amcgee@nida.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Statement of Work Project Title:Biostatistician Department:National Institute of Neurological Disorders & Stroke Office of Clinical Research Project Officer: Claudia S. Moy, PhD; Office of Clinical Research, NINDS Period of Performance: Base: December 05, 2013 - December 04, 2014 Option 1: December 05, 2014 - December 4, 2015 Option 2: December 05, 2015 - December 4, 2016 Background The Office of Clinical Research provides expertise to NINDS and investigators in the conception, design, and implementation of clinical research. OCR staff advises the Institute on clinical research methodology, research ethics, safety monitoring, clinical research budgets, clinical research data sharing, clinical trial reporting, and gender and minority tracking. In addition, OCR staff direct portfolios in specific neurological and clinical research areas, including: • Development of clinical interventions for neurological disorders and stroke • Comparing the effectiveness of interventions for neurological disorders • Epidemiological studies of neurological disorders • Translation of preclinical discoveries to clinical research (T1) and clinical practice (T2) • Innovation in clinical research methodology, research ethics, and protection of human subjects Purpose or Objective of the Requirement This contract is to provide the services of Biostatistician to support the management of a small portfolio of grants focused on statistical methodology, interact with clinical trial investigators to give them scientific information on our strategy with regards to statistical methods for trials as they prepare grant applications, advise other NINDS and OCR staff concerning biostatistical methodology, and advise NINDS on analysis and interpretation of NINDS-funded research. These activities are of particular importance as we anticipate a larger number of projects with adaptive designs or interim analyses. The Biostatistician will participate in Data and Safety Monitoring Board meetings as needed, attend seminars and give presentations with feedback on questions related to statistical methods in clinical research. Attendance at workshops of various research groups to advise on statistical design issues is also expected. Type of Contract Fixed Price Period of Performance December 5, 2013 through December 4, 2014 December 05, 2014 through December 4, 2015 December 05, 2015 through December 4, 2016 Level of Effort The NINDS will request these consulting services on an as-needed basis. The NINDS estimates a requirement for consulting services of up to 32 hours per month, over a period of 12 months. Contractor Requirements (Statement of Work) Prepares and reviews statistical analysis plans, provides detailed specifications for analysis files, consistency checks, tables, and figures; communicates with staff and investigators regarding statistical design and analysis issues. Interprets analyses and writes statistical sections of study reports. Performs statistical analyses as needed in order to advise NINDS on clinical trial matters. Performance of these tasks requires a Ph.D. and at least 10 years of experience in clinical trials, including trials in stroke and other neurological disorders as well as familiarity with a variety of the field's concepts, practices, and procedures. Extensive experience and scientific judgment are essential to plan and accomplish these goals. Confidential Treatment of Sensitive Information The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government or by persons or entities applying to or accepted to any clinical trials or studies during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer. Contractor agrees that it will not use the Confidential Information for any purpose except as set forth within this SOW, unless such time as such Confidential Information becomes public information through the efforts of participants in the clinical trials. Technical Evaluation Criteria Biostatistician Proposals for this procurement will be evaluated on the basis of experience, past performance, education and cost. NINDS reserves the right to make an award based on overall best value which shall be a technically superior proposal that adheres to the Government's best interest. 1.Understanding the Objective/Technical Approach20 points •Prepares and reviews statistical analysis plans, provides detailed specifications for analysis files, consistency checks, tables, and figures; communicates with staff and investigators regarding statistical analysis issues. •Interprets analyses and writes statistical sections of study reports 2.Experience 40 points •At least 10 years of experience in statistical design and analysis methodology in multicenter early phase and phase III clinical trials, including trials in stroke and other neurological disorders (provide examples). •Prior experience at the NIH or other Federal government agencies related to clinical trial design and analysis (provide at least two examples). 3.Education30 points •Requires a Ph.D. in Statistics or Biostatistics 4.Price10 points •The government will evaluate the total price contained in the offeror's proposal An overall rating of each proposal meeting the minimum requirement will be developed using a weighted combination of the technical and price proposals. Price proposals will be considered on the basis of total price. The business proposals will be evaluated to determine the reasonableness of the proposed price. The Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered. Award may be made on the basis of the initial proposal submitted without conducting any discussions; therefore the initial proposal should be submitted on the most favorable terms possible to the Government.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA(SS-SA)-2014-CSS287 /listing.html)
- Place of Performance
- Address: 6001 Executive Blvd, Rockville, Maryland, 20852, United States
- Zip Code: 20852
- Zip Code: 20852
- Record
- SN03411415-W 20140703/140702001507-75c69bf91971ad7af4eff1028200c784 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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