Biography
I am a biostatistician at Ora, Inc., a contract research organization specializing in ophthalmology studies, where I lead statistical analyses for early to mid phase clinical trials, including studies on dry eye disease and retinitis pigmentosa. I am responsible for ensuring compliance with regulatory requirements, developing statistical analysis plans, and coordinating with large, cross-functional teams, including one based in Hyderabad, India. I oversee the creation of key datasets, summaries, and graphical representations for clinical trial data, while maintaining a focus on data integrity, quality control, and timely project execution. Additionally, I represent the Statistical Operations Department at various regulatory and sponsor meetings
I graduated from the University of North Carolina in Chapel Hill where I received my B.S. in Statistics and Analytics and a minor in Data Science. I went on to receive my Master of Statistics from North Carolina State University, but I am still a Tarheel at heart!
I specialize in SAS and SQL, but I am also proficient with the R coding language for building models, analyzing complex datasets, and creating visualizations. I am currently working towards proficiency in Python in an effort to expand my working toolbox.
Download my resumé.
- Biostatistics
- Data Science
- Machine Learning
- Artificial Intelligence
- Sports Analytics
- Fishing
- Backpacking
Master of Statistics, 2023
North Carolina State University
B.S. in Statistics and Analytics, 2022
University of North Carolina at Chapel Hill
Minor in Data Science, 2022
University of North Carolina at Chapel Hill
Skills
Experience
Responsibilities include:
- Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed.
- Lead several early phase studies ranging from dry eye disease to retinitis pigmentosa comprised of a large team based in Hyderabad, India.
- Develop TLF shell documents for programmers to reference.
- Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives and statistical analyses defined in the protocol.
- Develop SDTM (Study Data Tabulation Model) and ADaM (Analysis Dataset Model) mapping documents and datasets.
- Program summary tables, data listings and graphical representations of clinical trials data.
- Ensure proper execution of all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data.
- Perform statistical QC of final clinical study reports by reprogramming important pieces of the programmed output.
- Contribute to the development of standard operating procedures for clinical trials.
- Represent Statistical Operations Department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed.
- Manage biostatistics timelines, budgets, and client expectations. *Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.
Responsibilities included:
- Instructed four sections of Introduction to Statistical Programming
- Met with 150 students each week to teach the basics of how to program in SAS
- Hosted office hours to assist students outside of class for three hours per week
- Graded every student’s homework assigments, quizzes, and final projects
- Communicated with students via email regarding questions and updates
- Supervised different learning management software such as Moodle and Yellowdig
Responsibilities for each summer included:
- Coding Listings and Tables in SAS
- Specing ADaM Datasets
- Reviewing SAPs
- Reviewing Outputs for Delivery to Clients
- Shelling Outputs
- Annotating CRFs
- Annotating Mock Shell Outputs
- Programming Studies for Deliveries
- Troubleshooting Pre-Existing Programs
- Addressing Client Comments to Output/Dataset Programs
Contact
- simonweisenhorn@gmail.com
- (704) 666-0010
- Chicago, IL 60657