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Clinical Data Scientist - HistoSonics
Data Scientist
Clinical Data Scientist responsible for designing and implementing data pipelines, statistical analyses, and predictive models to support histotripsy therapy development and regulatory submissions, leveraging Python, R, and SQL in a med‑tech environment.
About the role
Key Responsibilities
- Develop and maintain robust data pipelines to ingest, clean, and integrate multi‑modal clinical datasets from trials and real‑world evidence.
- Design and execute statistical analyses and machine‑learning models to evaluate safety, efficacy, and patient outcomes for histotripsy therapies.
- Collaborate with clinical, regulatory, and product teams to translate analytical insights into actionable recommendations for trial design and FDA submissions.
- Generate reproducible reports, visualizations, and dashboards for internal stakeholders and external partners.
- Ensure data integrity, compliance with GCP/21 CFR Part 11, and adherence to privacy regulations (HIPAA, GDPR).
Requirements
- Advanced degree (M.S. or Ph.D.) in Biostatistics, Bioinformatics, Computer Science, or related field with strong quantitative background.
- 5+ years of experience applying Python or R for clinical data analysis, statistical modeling, and machine‑learning in a regulated environment.
- Proficiency with SQL databases and data‑warehouse concepts; experience with cloud platforms (AWS, GCP) is a plus.
- Demonstrated ability to communicate complex analytical results to cross‑functional, non‑technical audiences.
- Familiarity with clinical trial processes, FDA regulatory requirements, and medical device data standards.
Skills
pythonmachine learningsql