Senior Research Epidemiologist with extensive experience at Research Triangle Institute, leading cross-functional teams in safety and efficacy studies. Expertise in epidemiological methods and data management, enhancing collaboration with global partners. Demonstrated success in regulatory compliance and scientific communication, resulting in impactful research outcomes in the pharmaceutical sector.
Overview
28
28
years of professional experience
Work History
Senior Research Epidemiologist
Research Triangle Institute-RTI Health Solutions-Pharmacoepidemiology and Risk Management Department
Research Triangle Park, NC
01.2008 - Current
Leads multi-functional teams to implement safety and efficacy studies on behalf of the leading pharmaceutical companies in America
Provides oversight of the day-to-day conduct of the study, liaising with data vendor, and preparing deliverables
Organizes efforts to prepare responses to regulatory requests on behalf of sponsors.
Organizes and performs technical functions for various systematic literature review projects.
Manage collaborations with global research partners needed for implementation of database studies.
Leads and coordinates further development and use of real-world data sources across clinical spaces with industry and regulatory stakeholders.
Works with other senior level leadership across offices on implementing and using observational and real-world data for pre-market decision making.
Provides support for company-wide diversity and inclusion programs.
Epidemiologist
SRA International (formerly Constella Group, LLC)-Epidemiology Department
Durham, NC
01.2006 - 01.2008
Investigated record linkage methods that produced linked multi-year vital record datasets.
Performed data requests, edits, cleaned data, and implemented data management protocols.
Applied knowledge to evaluate the linkage tool, LinkPro to inform client reports.
Presented findings on the strengths and limitations of LinkPro at stakeholder meetings and the client.
Involved in formative research, recruiting subjects, and primary survey data collection.
Research Associate
Measurement Incorporated-Research and Development Division-Psychometrics Department
Durham, NC
01.2004 - 01.2006
Performed analyses using operational as well as field test data to generate information needed for test development.
Planned and performed analyses for test equating.
Planned and coordinated standards setting and statistical review meetings for the company and state educational department clients.
Traveled with company for meetings with our clients to facilitate groups and assisted with psychometric duties.
Graduate Research Assistant
Pacific Institute for Research and Evaluation
Chapel Hill, NC
01.2003 - 01.2004
Worked as part of research team assisting with data analysis of data from the National Longitudinal Study of Adolescent Health
Lead efforts to develop manuscripts
Developed presentations to share results at professional meetings
Graduate Research Assistant
UNC-Chapel Hill-Department of Nutrition
Chapel Hill, NC
01.2002 - 01.2003
Worked as part of research team to coordinate research findings surrounding Northern Blot Analysis methodologies.
Developed presentation of results from original research
Lead the effort to prepare RNA for all experiments in the laboratory assigned.
Instructor
Halifax County Schools
Littleton , NC
08.2000 - 06.2002
Tracked student progress, frequently checking in with struggling students and identifying root causes of problems.
Evaluated and revised lesson plans and course content to achieve student-centered learning.
Applied various teaching aids to minimize learning gaps and instruct and motivate students.
Improved student performance by defining clear goals and communicating performance metrics.
Managed classes of up to 28 students for a 90-minute class period.
Research Assistant
Gillings School of Public Health
Chapel Hill, NC
08.1997 - 05.2000
Coordinated and managed laboratory projects and experiments for NIH RO1 Grant: Intracellular Signaling in Replicating Preadipocytes
Set and oversaw quality assurance guidelines for laboratory work.
Troubleshot and resolved equipment and process issues.
Performed experiments using Western Blot Analysis of signal transducers 1, 3, and 6.
Developed and delivered presentations describing the results of experiments.
Education
Master of Public Health - Maternal & Child Health
The University of North Carolina at Chapel Hill Gillings School of Public Health
Chapel Hill, NC
01.2004
BA - Sociology, Chemistry
The University of North Carolina at Chapel Hill College of Arts and Sciences
Chapel Hill, NC
01.2000
Skills
Project management
Data visualization and management
Regulatory compliance
Epidemiological methods and analysis
Scientific publication and communication
Collaboration and teamwork
Data interpretation
Affiliations
International Society of Pharmacoepidemiology, Active member of Membership Committee
Research And Publications
Foreman PK, Margulis AV, Alexander K, Shediac R, Calingaert B, Harding A, Pladevall-Vila M, Landis S. Birth prevalence of phenylalanine hydroxylase deficiency: a systematic literature review and meta-analysis. Orphanet J Rare Dis. 2021 Jun 3;16(1):253. doi: 10.1186/s13023-021-01874-6.
Gilsenan A, Fortuny J, Cainzos-Achirica M, Cantero OF, Flynn RWV, Garcia-Rodriguez L, Harding A, Kollhorst B, Karlsson P, Linner L, MacDonald TM, Odsbu E, Plana E, Ruigomez A, Schink T, Ziemiecki R, Andrews EB. Cardiovascular safety of prucalopride in patients with chronic constipation: a multinational population-based cohort study. Drug Saf. 2019 Oct;42(10):1179-90. doi: 10.1007/s40264-019-00835-0.
Ritchey ME, Harding A, Hunter S, Peterson C, Sager PT, Kowey PR, Nguyen L, Thomas S, Cainzos-Achirica M, Rothman KJ, Andrews EB, Anthony MS. Cardiovascular safety during and after use of phentermine and topiramate. J Clin Endocrinol Metab. 2019 Feb 1;104(2):513-22. doi: 10.1210/jc.2018-01010.
Gilsenan A, Harding A, Kellier-Steele N, Harris D, Midkiff K, Andrews E. The Forteo patient registry linkage to multiple state cancer registries: study design and results from the first 8 years. Osteoporos Int. 2018 Oct;29(10):2335-43. doi: 10.1007/s00198-018-4604-8.
Leiss JK, Lyden JT, Mathews R, Sitzman KL, Vanderpuije A, Mav D, Kendra MA, Klein C, Humphrey CJ. Blood exposure incidence rates from the North Carolina study of home care and hospice nurses. Am J Ind Med. 2009 Feb 1;52(2):99-104.
Harp JB, Franklin D, Vanderpuije AA, Gimble JM. Differential expression of signal transducers and activators of transcription during human adipogenesis. Biochem Biophys Res Commun. 2001 Mar 1;281(4):907-12.
Timeline
Senior Research Epidemiologist
Research Triangle Institute-RTI Health Solutions-Pharmacoepidemiology and Risk Management Department
01.2008 - Current
Epidemiologist
SRA International (formerly Constella Group, LLC)-Epidemiology Department
01.2006 - 01.2008
Research Associate
Measurement Incorporated-Research and Development Division-Psychometrics Department
01.2004 - 01.2006
Graduate Research Assistant
Pacific Institute for Research and Evaluation
01.2003 - 01.2004
Graduate Research Assistant
UNC-Chapel Hill-Department of Nutrition
01.2002 - 01.2003
Instructor
Halifax County Schools
08.2000 - 06.2002
Research Assistant
Gillings School of Public Health
08.1997 - 05.2000
Master of Public Health - Maternal & Child Health
The University of North Carolina at Chapel Hill Gillings School of Public Health
BA - Sociology, Chemistry
The University of North Carolina at Chapel Hill College of Arts and Sciences
Economic Growth & Agriculture Specialist at Research Triangle Institute (RTI)Economic Growth & Agriculture Specialist at Research Triangle Institute (RTI)
Procurement and Logistics Manager at Research Triangle Institute International- RTIProcurement and Logistics Manager at Research Triangle Institute International- RTI