Jen Ginsberg
Baltimore,USA
Summary
Motivated and results-driven professional with a proven track record in data analytics and process optimization. Identify business needs, and develop valuable solutions to drive accuracy and process efficiency. Drive business effectiveness through recommendations based on data findings.
Overview
17
17
years of professional experience
Work History
Operations Research Analyst, Data Standards Staff
U.S. Food and Drug Administration (FDA)
Silver Spring, USA
06.2021 - Current
- Serve as a subject matter expert and project manager on a contract that is developing data standards for the submission of real-world data
- Manage the team responsible for formulating a plan to move from the Structured Product Labeling (SPL) standard to Fast Healthcare Interoperability Resources (FHIR)
- Develop documentation on data standards policy, such as Federal Register Notices
- Prepare statements of work, budget requests, and other contracting activities
Operations Research Analyst, PMO
U.S. Food and Drug Administration (FDA)
Silver Spring, USA
06.2020 - 06.2021
- Supported senior management decision-making about IT investments
- Facilitate with multiple stakeholders to ensure the successful implementation of data analytics use cases
- Presented presentations and prepared reports for senior management
- Utilized technical expertise to provide recommendations on software selection, architecture design, and execution of IT projects
Clinical Data Scientist (detail)
U.S. Food and Drug Administration (FDA)
Silver Spring, USA
07.2019 - 06.2020
- Reviewed and evaluated clinical study protocols, reports, and study data submitted in New Drug Applications (NDAs) and Biologic License Applications (BLAs) for drug safety through a variety of analytical methods
- Utilized SAS, R, and Python to create automated tables and figures for safety data analyses
- Compiled presentation materials and held internal meetings related to the safety data analysis plan for each application assigned
Operations Research Analyst
U.S. Food and Drug Administration (FDA)
Silver Spring, USA
03.2016 - 09.2018
- Led the execution and implementation of IT projects designed to streamline the ANDA review process
- Managed contractor resources and led requirements-gathering sessions for new IT solutions
- Collaborated with reviewers to ensure IT solutions complied with regulatory guidance and policy requirements
- Created change management materials for various implementations
ORISE Fellow
U.S. Food and Drug Administration (FDA)
Silver Spring, USA
03.2015 - 03.2016
- Worked on a collaborative, interdisciplinary team seeking to improve CDER's Site Selection Model, which is used to select pharmaceutical facilities for inspection
- Participated in working groups with subject matter experts throughout the FDA on methodology
- Utilized SAS for ad hoc analyses and coding the Site Selection Model
Senior IT Data Analyst
OptumInsight, UnitedHealth Group
Frederick, USA
07.2014 - 02.2015
- Worked in the coordination of benefits department to ensure health insurance claims are being paid correctly for various private insurance providers, as well as Medicare and Medicaid, by using statistical analysis to look for trends and data inconsistencies
Epidemiologist
University of Maryland School of Medicine
Baltimore, USA
05.2012 - 07.2014
- Conducted various statistical analyses and modeling, utilizing the scientific principles of epidemiology
- Utilized data mining procedures to find associations with data from a chronic kidney disease observational study, and authored a manuscript
- I presented work at a National Kidney Foundation of Maryland conference, at weekly data meetings, and at faculty seminars to other statisticians, scientists, and colleagues
- Provided mentorship to medical students conducting analyses on study data
Graduate Research Assistant
University of Maryland Baltimore
Baltimore, USA
09.2010 - 02.2012
- Collaborated with the faculty on manuscripts utilizing public-use data, such as National Center for Health Statistics (NCHS) data sets
- Utilized SAS to perform data analysis using administrative and prospective data, and prepared tables, graphs, and presentations
Research Assistant
Johns Hopkins University School of Medicine
Baltimore, USA
07.2008 - 08.2010
- I researched the genetic mechanisms of lung disease in newborns, utilizing molecular biology techniques
- Analyzed DNA sequencing data, utilizing bioinformatics software, and ran PCR gels
- Collaborated with the principal investigator and other scientists on research and manuscripts
Education
Master's Certificate - Project Management
The George Washington University
01.2020
M.S. - Epidemiology
University of Maryland Baltimore
Baltimore01.2012
B.S. - Microbiology
University of Maryland, College Park
College Park01.2007
Skills
- Written and oral communication
- Data analysis and interpretation
- Data visualization
- Project management
- Problem solving
- Requirements gathering
- Data standards
- Regulatory compliance
- Strategic planning
- Stakeholder engagement
Publications
- Diamantidis CJ, Ginsberg JS, Yoffe M, Lucas L, Prakash D, Aggarwal S, Fink W, Becker S, Fink, JC, Remote usability testing and satisfaction with a mobile health medication inquiry system in CKD, CJASN, 2015, 10, 1364-1370
- Hsu KL, Fink JC, Ginsberg JS, Yoffe M, Zhan M, Fink W, Woods CM, Diamantidis CJ, Self-reported medication adherence and adverse patient safety events in CKD, Am. J. Kidney Dis., 2015, 66, 621-629
- Wu J, Ginsberg JS, Zhan M, Diamantidis C J, Chen J, Woods C, Fink JC, Chronic pain and analgesic use in CKD: Implications for patient safety, CJASN, 2015, 10, 435-442
- Ginsberg JS, Zhan M, Diamantidis CJ, Woods C, Chen J, Fink JC, Patient-reported and actionable safety events in chronic kidney disease, J Am Soc Nephrol, 2014, 25, 1564-1573
- Diamantidis C J, Fink W, Yang S, Zuckerman MR, Ginsberg J, Hu P, Xiao Y, Fink JC, Directed Use of the Internet for Health Information by Patients with Chronic Kidney Disease: Prospective Cohort Study, Journal of medical Internet research, 2013, 15, e251
- Hartley IR, Ginsberg JS, Diamantidis CJ, Zhan M, Walker L, Rattinger GB, Fink, JC, Consideration of ICD-9 Code Derived Disease Specific Safety Indicators in CKD, CJASN, 2013, 8, 2123-2131
- Gower WA, Wert SE, Ginsberg JS, Golan A, Whitsett JA, Nogee LM, Fatal familial lung disease caused by ABCA3 deficiency without identified ABCA3 mutations, J Pediatr, 2010, 157, 62-88
- Fink JC, Ginsberg JS, Roghmann M, Johnson JK, The frequency of both methicillin-sensitive and resistant Staphylococcus aureus colonization in pre-dialysis chronic kidney disease, Poster session presented at National Kidney Foundation of Maryland Scientific Session, 05/09/13, Baltimore, MD
Timeline
Operations Research Analyst, Data Standards Staff
U.S. Food and Drug Administration (FDA)
06.2021 - Current
Operations Research Analyst, PMO
U.S. Food and Drug Administration (FDA)
06.2020 - 06.2021
Clinical Data Scientist (detail)
U.S. Food and Drug Administration (FDA)
07.2019 - 06.2020
Operations Research Analyst
U.S. Food and Drug Administration (FDA)
03.2016 - 09.2018
ORISE Fellow
U.S. Food and Drug Administration (FDA)
03.2015 - 03.2016
Senior IT Data Analyst
OptumInsight, UnitedHealth Group
07.2014 - 02.2015
Epidemiologist
University of Maryland School of Medicine
05.2012 - 07.2014
Graduate Research Assistant
University of Maryland Baltimore
09.2010 - 02.2012
Research Assistant
Johns Hopkins University School of Medicine
07.2008 - 08.2010
Master's Certificate - Project Management
The George Washington University
M.S. - Epidemiology
University of Maryland Baltimore
B.S. - Microbiology
University of Maryland, College Park
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