Malikah McNeal, MPH
McLean,Virginia
Summary
Demonstrated success in public health, including epidemiology, statistical analysis and literature reviews. Skilled in technical writing, program evaluation, surveillance and research. Results-driven and proactive with a diligent, responsive and resourceful nature.
Overview
12
12
years of professional experience
Work History
Staff Fellow (Epidemiologist)
Food and Drug Administration (CDRH)
07.2022 - Current
- Provides comprehensive epidemiologic reviews of premarket and postmarket submissions in accordance with applicable regulations, policies, guidance documents, and standard operating procedures
- Provides action-oriented recommendations to ensure the safety and effectiveness of medical devices and provides science-based epidemiologic advice to cross-CDRH subject matter expert groups
- Serves as an epidemiologic consulting reviewer for various types of premarket applications for medical devices (or clinical studies of medical devices) including premarket notification submissions (510(k)s), De Novo petitions, premarket approval applications (PMAs), Humanitarian Devices Exemption applications (HDEs), Investigational Device Exemption (IDE) applications, and Pre-Submissions (Q-subs)
- Serves as an epidemiologic reviewer for various types of post-market actions including reviews of protocols for 522 and Post-Approval Studies, which are completed in accordance with statutory deadlines and implements ideas to improve the progress of studies that are not performing in accordance with approved study timelines
- Provides epidemiologic analyses in conjunction with medical device recalls, Establishment Inspection Report (EIR) reviews, complaints and allegations of regulatory misconduct, and manufacturing site changes
- Applies epidemiologic expertise to evaluate information pertaining to various types of joint arthroplasty devices
- Enhances professional career development by collaborating with other scientists to obtain a greater understanding of problems associated with medical devices and keeps abreast of current events and findings, as well as changes in the law and regulations affecting medical devices by careful scrutiny of scientific and legislative literature and by attending scientific meetings.
Health Researcher III (Contractor)
CDC - National Center for Health Statistics
09.2020 - 05.2022
- Provided expertise to support the planning, development, and implementation of the National Health Care Surveys (National Electronic Health Records Survey, National Hospital Care Survey, etc.)
- Conducted analysis in SAS using data collected from health care providers to produce special tabulations on issues of concern in processing EHR and claims data, data quality, and linkage for the development of reports and manuscripts
- Prepared public use files with associated documentation and restricted use files for the NCHS Research Data Center
- Participated in the development and review of Morbidity and Mortality Weekly Reports (MMWR), web tables, and data briefs on topics related to EHR adoption and use, interoperability, health information exchange, etc
- Used the National Hospital Care Survey to respond to questions related to the use of International Classification of Diseases, ICD-10 coding and Natural Language processing in monitoring the opioid epidemic and topics related to health disparities for the development of manuscripts for publication in professional journals.
Epidemiologist (Independent Contractor)
Maxim Healthcare Services
07.2020 - 09.2020
- Provided case investigation, medical record review, data management, and analytic support to Prince George's County Health Department (Largo, MD) and San Antonio Metropolitan Health District (San Antonio, TX) to support COVID-19 response
- Contacted positively tested cases to conduct interviews and provide education and instructions on isolation
- Analyzed epidemiological data received from testing sites, laboratories, and patients to measure the effectiveness of interventions provided to high-risk county residents on an as needed basis.
Health Science Analyst (Contractor)
National Institute of Allergy & Infectious Disease
01.2020 - 07.2020
- Provided support to various divisions across the institute by performing quantitative and qualitative analyses of large volumes of data associated with programmatic and scientific portfolios
- Responsible for analyses of reports and program data to identify programmatically significant findings
- Contributed to the development of portfolio analysis tools using the design, testing and implementation of new tools and improvement of existing tools
- Fostered and conducted investigations of new approaches and methods to enhance existing portfolio analysis techniques.
Scientific Program Analyst (Contractor)
National Institutes of Health - Office of the Director
05.2018 - 01.2020
- Provided support to the Environmental Influences on Child Health Outcomes program to ensure satisfactory completion of program requirements by grantees for Observational Studies as well as the IDeA States Pediatric Clinical Trials Network (ISPCTN)
- Analyzed program related activities and prepared reports including graphics and charts to summarize the progress of grantees using Word, Excel, Power point, and internal NIH databases (QVR, iSearch, INSPIRE, PubMed, etc.)
- Collaborated with program officials and Chief of Staff on a regular basis to monitor & evaluate yearly milestones using progress reports from awardees and documents any concerns for further discussion at internal office meetings
- Maintained content on the SharePoint site to allow Trans-NIH members to remain familiar with ECHO practices
- Collaborated with the coordinating center and data analysis center to collect, store, and analyze data from nearly 50,000 children and their mothers
- Collaborated with grantees to ensure compliance with NIH genomic and non-genomic data sharing policies and human subjects protection
- Ensured satisfactory operation of various committee meetings & scientific workshops and develops meeting materials including agendas, action items, and summary of discussions.
Statistical Analyst (Contractor)
USDA-Agricultural Research Service
02.2017 - 05.2018
- Developed and implemented strategies for data analysis, interpretation and applications using MS Access, Excel, and SAS software programs
- Extracted data from the National Health & Nutrition Examination Survey (NHANES) and merge several datasets to determine sampling plans for nutritional products using weighted frequencies
- Performed descriptive statistics on a regular basis and utilized a mixed methods model to generate predicted mean values, standard errors, and confidence intervals
- Developed data sets for web release that may be used by nutritional epidemiologists and other researchers that may be further utilized to answer more advanced research questions
- Identified systematic issues with data, develops solutions and resolves any inconsistencies to ensure quality
- Provided documentation for changes made in data and drafts documents for reports, web releases, and manuscripts.
Data Analyst (Contractor)
Bio-Telemetry Research
11.2016 - 02.2017
- Provided SAS programming and data management using electronic medical record data to produce data sets and ensure quality standards in support of clinical trial research studies performed at various client sites
- Monitored data quality through adherence to established protocols on a continuous basis
- Selected statistical methods for data analysis immediately following the creation of a reporting database.
Research Associate (Temporary, Grant Funded)
GWU- Milken School of Public Health
11.2015 - 11.2016
- Provided support to the Evaluating Cancer Survivorship Care Models study funded by the Patient Centered Outcomes Research Institute (PCORI)
- Collaborated with medical sites regularly to address concerns and receive important updates to track milestones and collect data needed for monthly progress reports
- Updated internal research team on patient enrollment at bi-weekly meetings and upon request for written reports and other submitted documents to PCORI
- Collaborated with staff on the management of program budget and prepared statements of work for clinical sites
- Managed data collected from over 1,000 research participants by scheduling, training, and providing supervision to Research Assistants using RED Cap software, Microsoft Excel, and other tracking tools daily
- Cleaned, processed, and analyzed longitudinal survey data through the re-coding of variables to ensure consistency, provide descriptive statistics, chi-square testing, analysis of variance, and other analyses to support a mixed methods model using SAS (Statistical Analysis Software)
- Summarized analytical results at internal research meetings.
Data Analyst
Virginia Department of Health- Division of Environmental Epidemiology
03.2015 - 11.2015
- Data management and reporting to support the waterborne hazards and rabies control programs using an EPA derived BMAN (Beach Monitoring and Notification) database and pivot sheets
- Collected, entered, cleaned, and analyzed data using Microsoft Excel, Dreamweaver, SAS, and SPSS software
- Collaborated with several local health departments to ensure data quality and validity of water quality results reported to the Environmental Protection Agency (EPA)
- Submission of data to EPA to meet reporting requirements using XML files
- Partnered with information management staff to develop and maintain customized web pages with updated content and statistical information to notify the general population of water quality results and rabies cases
- Prepared information to answer data requests, off-site presentations, internal and external evaluation reports.
Mid-Atlantic Twin Registry (MATR) Interviewer
Virginia Commonwealth University- Medical College of Virginia
05.2014 - 11.2015
- Conducted telephone interviews using Computer Assisted Telephone Interviewing (CATI)
- Contacted adult twins and parents of juveniles regarding registration with the MATR or participation in specific research projects conducted on various health-related topics
- Collaborated with the project coordinator to resolve issues related to participant inquiries, questions, or complaints
- Followed confidentiality procedures for the protection of a participant's right to privacy.
Every Woman's Life Quality Control Coordinator (Data Manager)
Virginia Department of Health-Division of Health Promotion & Prevention
10.2013 - 03.2015
- Managed the data collection and reporting system for timely collection of program data required by federal funders
- Developed mechanisms to ensure the recovery of database information and tracking of errors in quality and validity
- Partnered with federal contractors to develop or modify EWL data system to achieve program goals
- Collaborated with an on-site Clinical Coordinator to ensure the data reporting system reflected current medical and nursing standards for breast and cervical screening and cancer treatment
- Utilized appropriate information to determine the state cancer burden for reporting and evaluation
- Served as the liaison between the CDC and the program on all data-related issues
- Performed site visits and provided in-person training to improve provider performance
- Prepared information to answer data requests, off-site presentations, internal and external evaluation reports.
Student Epidemiology Methods I Project
Eastern Virginia Medical School
10.2012 - 12.2013
- Cross-sectional study on the effect of C-reactive protein levels on cardiovascular disease
- Performed literature reviews to determine the relevance of research topic and presence of existing research using electronic medical journals (Journal of American Medical Association (JAMA), New England Journal of Medicine (NEJM), etc.)
- Analyzed data using Laboratory and Questionnaire data from the NHANES (National Health and Nutrition Examination Survey) 1999-2002 database
- Chi-square testing was used to describe the strength of association between C-reactive protein and HDL (High Density Lipoprotein) levels
- SAS (Statistical Analysis Software) used for data analysis and management.
Graduate Research Practicum
Eastern Virginia Medical School
04.2013 - 08.2013
- Cross-sectional study on the effect of Cadmium and Lead Exposure on hearing in individuals aged 12 years and older
- Performed literature reviews to determine the extent of existing research using several online scholarly journal articles pertaining to audiometry
- Goal was to determine if exposure to Cadmium and Lead are correlated with hearing loss while controlling for occupational and non-work-related noise as potential confounders
- Multivariate logistic regression analysis performed using laboratory and questionnaire data from the NHANES (National Health and Nutrition Examination Survey) 2007-2008 database
- SAS (Statistical Analysis Software) used for data analysis and management.
Graduate Research Practicum
Eastern Virginia Medical School/Jones Institute for Reproductive Medicine
08.2012 - 04.2013
- Prospective Cohort study on the effect of NSAIDS (Non-Steroidal Anti-Inflammatory Drugs) on fertility in women ages 18-35 with rheumatoid arthritis
- Patients meeting inclusion criteria recruited from Rheumatology doctor's offices
- Goal is to determine if the intake of NSAIDS is correlated with infertility in rheumatoid patients
- Preparation of a telephone interview script and survey tool using inclusion and exclusion criteria
- Data collection from rheumatoid arthritis patients using the telephone interview survey.
Education
Master of Public Health - Epidemiology Track
Eastern Virginia Medical School
08.2013
B.S. Biological Sciences -
Old Dominion University
05.2010
Skills
- Microsoft Office (Word, Excel, Access, PowerPoint, Outlook)
- SAS
- RED Cap
- NIH databases (QVR, iSearch, INSPIRE, NIH Reporter, PubMed)
- Data translation
- Research protocols
- IRB Procedures
- Good Clinical Practice guidelines
- Title 21 Code of Federal Regulations
- Data analysis
- Program evaluation
- Scientific Writing
- Reporting Requirements
- Research Procedures
- Research Protocols
- Hypothesis Testing
Student Projects Internships
- Eastern Virginia Medical School, Cross-sectional study on the effect of Cadmium and Lead Exposure on hearing, 04/2013, 08/2013, Multivariate logistic regression analysis performed using laboratory and questionnaire data from the NHANES database
- Eastern Virginia Medical School, Cross-sectional study on the effect of C-reactive protein levels on cardiovascular disease, 10/2012, 12/2013, Chi-square testing was used to describe the strength of association between C-reactive protein and HDL levels
- Eastern Virginia Medical School/Jones Institute for Reproductive Medicine, Prospective Cohort study on the effect of NSAIDS on fertility in women with rheumatoid arthritis, 08/2012, 04/2013, Data collection from rheumatoid arthritis patients using telephone interviews
Publications
- Reproductive History and Postmenopausal Rheumatoid Arthritis Among Women 60 Years or Older: Third National Health and Nutrition Examination Survey, 2013, http://journals.lww.com/menopausejournal/Abstract/2013/09000/Reproductive_history_and_postmenopausal.10.aspx
- Dietary Supplement Ingredient Database (DSID) and the Application of Analytically Based Estimates of Ingredient Amount to Intake Calculations, 2018, https://academic.oup.com/jn/article/148/suppl_2/1413S/5064355
- QuickStats: Distribution
- Of Hours per Day That Office-Based Primary Care and Specialist Care Physicians Spent Outside Normal Office Hours Documenting Clinical Care in Their Medical Record System†- United States, 2019, 2021
References
References available upon request.
Timeline
Staff Fellow (Epidemiologist)
Food and Drug Administration (CDRH)
07.2022 - Current
Health Researcher III (Contractor)
CDC - National Center for Health Statistics
09.2020 - 05.2022
Epidemiologist (Independent Contractor)
Maxim Healthcare Services
07.2020 - 09.2020
Health Science Analyst (Contractor)
National Institute of Allergy & Infectious Disease
01.2020 - 07.2020
Scientific Program Analyst (Contractor)
National Institutes of Health - Office of the Director
05.2018 - 01.2020
Statistical Analyst (Contractor)
USDA-Agricultural Research Service
02.2017 - 05.2018
Data Analyst (Contractor)
Bio-Telemetry Research
11.2016 - 02.2017
Research Associate (Temporary, Grant Funded)
GWU- Milken School of Public Health
11.2015 - 11.2016
Data Analyst
Virginia Department of Health- Division of Environmental Epidemiology
03.2015 - 11.2015
Mid-Atlantic Twin Registry (MATR) Interviewer
Virginia Commonwealth University- Medical College of Virginia
05.2014 - 11.2015
Every Woman's Life Quality Control Coordinator (Data Manager)
Virginia Department of Health-Division of Health Promotion & Prevention
10.2013 - 03.2015
Graduate Research Practicum
Eastern Virginia Medical School
04.2013 - 08.2013
Student Epidemiology Methods I Project
Eastern Virginia Medical School
10.2012 - 12.2013
Graduate Research Practicum
Eastern Virginia Medical School/Jones Institute for Reproductive Medicine
08.2012 - 04.2013
Master of Public Health - Epidemiology Track
Eastern Virginia Medical School
B.S. Biological Sciences -
Old Dominion University
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