Elisabeth Kilroy
Senior Manager, Biostatistics and Data Management at Aquestive Therapeutics
- Role
- Senior Manager, Biostatistics and Data Management at Aquestive Therapeutics
- Location
- Columbia, MD, US
- LinkedIn followers
- 500 followers
About Elisabeth Kilroy
Dynamic and passionate data scientist who excels in data analysis, visualization, and…
Experience
Senior Manager, Biostatistics and Data Management
Apr 2024 — Present
Spearhead the biostatistical, clinical data management, and data analysis pipelines for AQST-109 program, including individual Phase I – studies and NDA submission- Serve as lead internal biostatistician and data manager, working collaboratively with CROs to create and execute statistical analysis and data management plans, CRF development, implementation and validation within the EDC, and provide ongoing support, both technical and clinical, for efficient action and resolution of data queries- Conduct rigorous reviews of study-level and integrated CDISC packages, TLFs, and clinical study reports to ensure the delivery of high-quality data that complies with stringent regulatory standards- Draft and execute standard operating procedures that address gaps in clinical data governance and keep pace with the evolving clinical data landscape and regulatory requirements such as managing access and transferring datasets and analyses with CROs and third-party vendors- Perform ad-hoc statistical analyses and cross-study comparisons and provide effective data visualizations for corporate presentations, press releases, and regulatory documents.
Education
College of Charleston
Bachelor of Science (B.S.), Exercise Science and minor in Neuroscience
2010 — 2014
Wake Forest University
Kinesiology and Exercise Science
2010 — 2011
University of Maine
Doctor of Philosophy (PhD), Biomedical Sciences
2015 — 2020
Skills
- Time Management
- Microsoft Office
- Powerpoint
- Microsoft Excel
- Data Analysis
- Leadership
- Photoshop
- Research
- Photography
- Microsoft Word
- Public Speaking
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