Data Scientist - Remote, USA

Role overview Turn clinical, preclinical, and real-world health data into reliable evidence for decisions across a medical-device product lifecycle. The work combines data science and biostatistics: shaping research questions into analysis-ready datasets, supporting study design and execution, and communicating findings with appropriate context and limitations.

Responsibilities - Translate research questions into cohort definitions, data requirements, analysis plans, and clear deliverables. - Assess the provenance, quality, and suitability of electronic health records, claims, clinical data, and other sources; build reproducible data preparation and quality-check workflows. - Support real-world evidence and post-market analyses, including subgroup and trend assessments related to device safety and performance. - Advise on study design, endpoints, analysis populations, sample-size or precision considerations, and data collection for preclinical and clinical studies. - Develop or maintain analysis plans, programming specifications, datasets, and reporting materials; perform and quality-check descriptive and inferential analyses. - Document methods and assumptions, interpret results, and present findings for study reports, regulatory materials, publications, and cross-functional teams.

Requirements - Bachelor’s degree in a quantitative or health-related field with at least 7 years of relevant experience, or a related master’s degree with at least 5 years. - Practical R experience for preparing, analyzing, visualizing, and validating complex data. - Experience translating research questions into defined datasets, analysis plans, and reproducible workflows. - Background in statistical analysis of clinical, preclinical, observational, or other health-related data, with working knowledge of study design and endpoint definition. - Ability to document and quality-check statistical programs and outputs, communicate clearly, and collaborate across disciplines.

Nice to have A graduate degree, familiarity with SAS, Python, or SQL, and experience with real-world data, electronic health records, clinical research, or regulated medical-device or pharmaceutical work. Knowledge of GCP, ISO 14155, ICH E9, or relevant FDA guidance is useful.

Benefits and work setup Full-time, remote role in the United States with up to 10% travel. Stated base salary is $135,000–$155,000, plus a variable incentive plan, stock options, 401(k), health insurance, and paid vacation.