Biostatistical Data Analyst

6 days ago


Richmond, Virginia, United States NIRSense Inc. Full time
About the Role

NIRSense Inc. is a pioneering cardiology company dedicated to developing innovative non-invasive medical devices.

We are seeking a highly skilled Biostatistician/Data Scientist to join our team and contribute to the development of our optical medical sensor products and other projects across a large research portfolio.

The successful candidate will be responsible for conducting statistical analyses of clinical validation study data, ensuring that product performance, safety, and efficacy are rigorously assessed.

Key Responsibilities
  • Conduct statistical analyses of clinical trial data with complex structures using advanced techniques such as linear mixed-effects models and generalized linear models.
  • Develop and implement statistical methodologies tailored to specific study designs, including regression analysis, survival analysis, and repeated measures analysis.
  • Prepare statistical sections of clinical study reports, regulatory submission documents, and 510(k) applications to support FDA clearance.
Requirements
  • Master's degree or PhD in Biostatistics, Mathematics, or similar discipline with at least three (3) years of professional experience as a biostatistician, data scientist, or statistical analyst in the medical device industry.
  • Proficiency in statistical software such as R, SAS, or SPSS; experience with specialized software for mixed-effects modeling is highly preferred.
  • Strong knowledge of advanced statistical methods, including linear mixed-effects models, survival analysis, and longitudinal data analysis.
Estimated Salary

$125,000 - $145,000 per year, depending on experience.



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