Post by pepo on Jun 4, 2014 23:13:19 GMT -4
Semantic Web Development Fellowship
Office of Computational Science
Office of Translational Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD
FDA-CDER-2014-0039
Project Description:
A fellowship opportunity is currently available in the Office of Computational Science (OCS) within the Office of Translational Sciences (OTS) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).
OTS was established to promote efficient and informative study designs and data analysis methods to quantitatively evaluate the efficacy, safety and dosing of drugs through collaboration among the Office of Biostatistics, Office of Clinical Pharmacology, and other offices in CDER and Centers in FDA. Sponsors will submit clinical trial data in marketing applications (i.e., New Drug Applications and Biologic License Applications) to support efficacy and safety assessments during the review process. The integrity of the submitted data is assessed through inspections of the investigational sites that collect the data; however, resource limitations prevent the inspection of all sites. Instead, OCS uses a risk-based approach that attempts to target high-risk sites for inspections. This process requires the submission and analysis of site-specific study data.
Currently, OCS has no automated processes, or the technology infrastructure, to receive, validate, store and analyze the data from these submissions. This results in manual, labor intensive data management and analysis processes that are inefficient and error prone. The selected participant will join OCS efforts to improve the management and analysis of clinical trial data to support site selection, inspection, and review processes through the use of semantic web standards and technologies (e.g., RDF, OWL, SPARQL).
The Research Participation Program for FDA is administered by the Oak Ridge Institute for Science and Education (ORISE). The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend depending on educational level and experience. The participant must show proof of health insurance. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.
Qualifications:
A Bachelor’s or Master’s (preferred) degree in computer science received within the last five years.
Knowledge/skills in: RDF; RDFS; SKOS; OWL; SPARQL is desired.
Knowledge/skills in biomedical terminologies and ontologies is desired (e.g. LOINC, SNOMED CT, MedDRA, OBO)
One to three years of experience in XML programming is desired. Knowledge/skills in: XML; XML schemas (XSD); XSLT; XPath, XQuery; xForms, XSLTForms; XSLT-FO (Formatting Objects); and Schematron is desired.
How to Apply:
To be considered, please send a current CV/resume to the attention of OTSORISE@fda.hhs.gov Please reference FDA-CDER-2014-0039 in all communications.
Office of Computational Science
Office of Translational Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD
FDA-CDER-2014-0039
Project Description:
A fellowship opportunity is currently available in the Office of Computational Science (OCS) within the Office of Translational Sciences (OTS) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).
OTS was established to promote efficient and informative study designs and data analysis methods to quantitatively evaluate the efficacy, safety and dosing of drugs through collaboration among the Office of Biostatistics, Office of Clinical Pharmacology, and other offices in CDER and Centers in FDA. Sponsors will submit clinical trial data in marketing applications (i.e., New Drug Applications and Biologic License Applications) to support efficacy and safety assessments during the review process. The integrity of the submitted data is assessed through inspections of the investigational sites that collect the data; however, resource limitations prevent the inspection of all sites. Instead, OCS uses a risk-based approach that attempts to target high-risk sites for inspections. This process requires the submission and analysis of site-specific study data.
Currently, OCS has no automated processes, or the technology infrastructure, to receive, validate, store and analyze the data from these submissions. This results in manual, labor intensive data management and analysis processes that are inefficient and error prone. The selected participant will join OCS efforts to improve the management and analysis of clinical trial data to support site selection, inspection, and review processes through the use of semantic web standards and technologies (e.g., RDF, OWL, SPARQL).
The Research Participation Program for FDA is administered by the Oak Ridge Institute for Science and Education (ORISE). The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend depending on educational level and experience. The participant must show proof of health insurance. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.
Qualifications:
A Bachelor’s or Master’s (preferred) degree in computer science received within the last five years.
Knowledge/skills in: RDF; RDFS; SKOS; OWL; SPARQL is desired.
Knowledge/skills in biomedical terminologies and ontologies is desired (e.g. LOINC, SNOMED CT, MedDRA, OBO)
One to three years of experience in XML programming is desired. Knowledge/skills in: XML; XML schemas (XSD); XSLT; XPath, XQuery; xForms, XSLTForms; XSLT-FO (Formatting Objects); and Schematron is desired.
How to Apply:
To be considered, please send a current CV/resume to the attention of OTSORISE@fda.hhs.gov Please reference FDA-CDER-2014-0039 in all communications.