Senior Statistical Programmer (Oncology)

Natera • Remote • 31 days ago

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.

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