Salary
💰 $120,300 - $150,400 per year
About the role
- This is an exciting opportunity to participate in advancing Natera’s oncology product portfolio of cutting-edge diagnostic tests. As a Senior Statistical Programmer, you will leverage your strong R programming skills and clinical trials background to contribute to the analysis and reporting of clinical trials supporting multiple regulatory submissions.
- Primary programmer for one or more clinical validation studies supporting in vitro diagnostic submissions (e.g., IVDR, 510(k), CTA/CDx/PMA, etc.) including analysis datasets and Tables, Figures and Listing (TFL) generation.
- Contribute to programming infrastructure, including R package development and maintenance.
- Collaborating with statisticians, clinical teams, and data managers
- Creating and maintaining programming specifications for analysis datasets
- Performing data cleaning, transformations, and quality checks
- Perform programming validation and ensuring data integrity.
- Supporting regulatory submissions by generating required analysis datasets, TLFs and documentation
Requirements
- Bachelor’s in statistics, mathematics, computer science, or related field.
- 3+ years related experience with at least 1 years experience in Clinical Trial analysis.
- At least 2 years R programming experience.
- Proficient in R programming including building and maintaining packages.
- Experience in analysis dataset and TFL generation.
- Prior experience in NGS, genetics, and/or oncology diagnostics preferred.
- Experience maintaining statistical computing environments a plus.
- Experience with CDISC standard including SDTM, and ADaM is a plus
- Experience with R Shiny development for data visualization and reporting preferred