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Role Description

We are seeking an experienced Contract Biostatistician to provide part-time statistical consulting support for a growing medical device company. This role will focus on the design, analysis, and interpretation of clinical studies involving human subjects, with an emphasis on diagnostic device performance and sensitivity testing. The ideal candidate has prior experience working with medical device clinical data and can operate independently in a fast-paced, resource-lean environment.

• Provide statistical expertise for medical device studies involving human patients, including study design, analysis planning, and interpretation of results
• Support diagnostic device studies, including evaluation of sensitivity, specificity, and other performance characteristics
• Conduct and review sensitivity analyses to assess robustness of study results
• Develop or review statistical analysis plans (SAPs) for device clinical studies
• Analyze clinical and diagnostic data and summarize results for internal teams and external stakeholders
• Collaborate with clinical, regulatory, and engineering teams to support regulatory submissions and study reporting
• Provide ad hoc statistical consultation as needed

Qualifications

• Prior experience supporting medical device clinical studies involving human subjects
• Hands-on experience with diagnostic studies, including sensitivity analyses
• Strong knowledge of statistical methods relevant to medical device evaluation
• Ability to work independently as a consultant and communicate findings clearly to non-statistical stakeholders

Requirements

• Master’s degree in Statistics, Biostatistics, or a related field
• Experience supporting studies intended for regulatory submission (e.g., FDA, notified bodies)
• Familiarity with common statistical software (e.g., SAS, R, or equivalent)