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 RESPONSIBILITIES:
- 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
QUALIFICATIONS:
- 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.
KNOWLEDGE, SKILLS, AND ABILITIES:
- 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
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.