Resume

Experience

Senior Manager, Clinical Data Standards

Medidata AI

Medidata Solutions

I act as a SDTM subject matter expert, supporting all SDTM programming and regulatory submission-related activities with the internal team and vendors.
I provide technical expertise for SDTM activities, help implement proprietary algorithmic data standardization models, and develop automation of internal processes.
I develop and manage best practices for data standardization to provide high-quality, regulatory-compliant standardized data including the development cross functional SOPs, Working Procedures and Guidance documents.
I review outputs of data standardization algorithms and automated statistical reports on multiple pooled trials, validate mappings, and make recommendations to improve data quality and model performance.
I help manage vendors and oversee deliverables.
I lead and conduct quality control for data standardization and regulatory submissions activities.
I act as a knowledge and training resource to our teams on SDTM and clinical data capture practices.

Clinical Data Standards Manager

Medidata AI

Medidata Solutions

Data Analyst

Biostatistics Department

I was the department lead for SDTM for Clinical Data Review meetings.
I was the department lead for the validation of all cardiovascular, neurological, liver, and endocrine related studies.
I was the department’s therapeutic expert for endocrine related indications.
I managed a small team of 5 SDTM programmers.
I assigned duties for our group of 50+ programmers.
I led numerous quality improvement initiatives to improve the operations of the department.
Lead biweekly training seminars.
I created annotated CRFs per CDISC SDTM standard, mapping specifications for study level data collection source data to CDISC SDTM, and created SDTM data via custom SAS programming.
I performed the validation of CDISC SDTM data in accordance with SOPs and ensured SDTM data conforms to the data standards expected by regulatory agencies.
I started as an entry level, promoted 3 times in 4 years.

Medpace

Research Assistant

Mathematics Department

Ohio University

I co-authored a biomathematical paper on Saccharomyces cerevisiae. I used Matlab to create the primary programs in the paper. I executed hundreds of thousands of simulations using the programs and recorded the results in excel. I eventually created a program to analyze the results of the simulations more efficiently.
I reviewed over 100 academic papers in the areas of mathematics and biology to contribute to the theory for our paper.
I attended weekly dynamical systems seminars and biweekly biomathematics seminars.

Northern Kentucky University

Masters of Science in Health Informatics

My Masters project was "Quality Control Tool for Creating and Managing Changes in SDTM Regulatory Packages".

Ohio University

Graduate Coursework in Applied Mathematics

Graduate Recruitment Scholarship (2017-2018)

Ohio University

Bachelor of Science in Applied Mathematics

Ohio Achievement Scholarship (2014-2017)

Ohio Distinction Scholarship (2014-2017)

Ohio Promise Scholarship (2014-2017)

Frank Hartsell & Family Scholarship (2014-2017)

Ohio Pathway Scholarship (2014-2016)

Ohio Chemistry Contest Scholarship (2014-2015)