Biostatistician, Health

What you'll do

• Serve as the primary statistical lead for clinical validation studies from concept through submission.
• Design study protocols and author Statistical Analysis Plans (SAPs) and Clinical Study Reports (CSRs).
• Plan supplemental data collection to ensure a single study supports multiple future features.
• Ensure the statistical validity of product claims and messaging for regulatory and marketing teams.
• Maintain scientific integrity by managing blinding, pre-specification of analyses, and control of multiplicity.
• Translate complex clinical questions into appropriate statistical assessments using existing datasets.
• Develop reusable study templates and standardized processes to improve team efficiency.
• Communicate results through internal reports and formal regulatory submissions.

What we're looking for

• PhD or Master's degree in biostatistics, statistics, biomedical engineering, epidemiology, public health, or a related quantitative field.
• Working proficiency in R, Python, or SAS including experience building statistical infrastructure and reproducible analysis pipelines.
• Demonstrated experience authoring clinical study documentation such as statistical analysis plans and clinical study reports.
• Familiarity with frequentist and Bayesian methods, adaptive designs, or real-world evidence approaches.
• Practical knowledge of GCP and the regulatory framework governing medical device clinical investigations.
• Demonstrated ability to bridge discussions between engineering and clinical experts.
• Therapeutic expertise in cardiology, women's health, or neurology (preferred).
• Experience with diagnostic accuracy studies, high-frequency longitudinal data, or large-scale decentralized trials (preferred).