Clinical Data Scientist

Overview

About our Company:

Exagen is a patient-focused and discovery-driven life sciences company dedicated to transforming the care continuum for patients suffering from debilitating and chronic autoimmune diseases. Our goal is to enable rheumatologists to improve care for patients through the differential diagnosis, prognosis, and monitoring of complex autoimmune and autoimmune-related diseases, including lupus and rheumatoid arthritis. By leveraging our proprietary Cell-Bound Complement Activation Products, or CB-CAPs, technology, we help get to the real cause of a patient’s symptoms and guide their journey to improved health.

About the Opportunity:

The Clinical Data Scientist (CDS) turns Exagen’s clinical, serologic, and laboratory data into analysis-ready datasets, reproducible pipelines, and machine learning applications that accelerate our validation studies, publications, and product development. The CDS owns dataset curation and clinical database development across the Company’s registry, biobank, and study data; applies machine learning and AI approaches—including large language model (LLM)-assisted workflows—in partnership with the data science team;

and delivers analysis-ready data to biostatistics. In a supporting capacity, the CDS provides clinical data management for studies sponsored by Exagen and studies where Exagen serves as a central laboratory, with mentorship from the Clinical Affairs team and the opportunity to grow into broader clinical study operations.

Primary Responsibilities:

Note:

Other duties may be assigned.

• Design, build, and maintain analysis-ready clinical datasets from the Company’s SQL databases, EDC platform, laboratory information system (LIS), registry, and biobank sources in support of validation studies, publications, and regulatory deliverables.
• Develop and maintain reproducible data preparation and quality-control pipelines in Python and SQL, with appropriate documentation and version control.
• Apply machine learning approaches to multi-analyte serologic and clinical data to support assay interpretation and algorithm development, in partnership with the data science team.
• Develop and evaluate AI-assisted workflows (e.g., LLM-assisted literature surveillance, structured data extraction, and medical affairs content support) with appropriate human review and in compliance with Company policies.
• Partner with biostatistics to deliver clean, well-documented, analysis-ready datasets supporting statistical analyses of clinical and validation studies, including curation and harmonization of registry, biobank, and real-world data across the Company’s autoimmune disease areas.
• Prepare data quality reports, study metrics, and internal dashboards, and ensure data handling practices comply with applicable GCP/ICH guidelines, HIPAA, CLIA requirements, study protocols, and SOPs.

Supporting Responsibilities:

Note:

These activities are shared with, and mentored by, the Clinical Affairs team; candidates are not expected to arrive with deep expertise in every area.

• Provide clinical data management for studies sponsored by the Company and studies where Exagen serves as a central laboratory, including data management plans, data reconciliations, release of data clarification forms, query resolution, dataset locks, manual release of test reports, and preparation of reports for invoicing, in coordination with study sponsors and/or CROs.
• Assist in the design of CRFs and the management of study builds, edit checks, and data exports within the EDC platform used by the Company.
• Support day-to-day operations of Company-sponsored studies in compliance with GCP/ICH guidelines, study protocols, SOPs, and other regulatory requirements, including maintenance of the Trial…