Clinical Data Scientist

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 patients symptoms and guide their journey to improved health.

About the Opportunity:

The Clinical Data Scientist (CDS) turns Exagens 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 Companys registry biobank and study data; applies machine learning and AI approachesincluding large language model (LLM)-assisted workflowsin partnership with the data science team; and delivers analysis-ready data to 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 Companys 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 Companys 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 Master File (TMF) system.
• Support communications with investigative sites and maintain logs of study activities including patient enrollment completion of case report forms and documentation of clinical research study samples received in the lab.
• Work with the data engineering team to ensure that data collected via the EDC and other instruments is captured versioned and quality-controlled in the Companys SQL database.
• Assist in training research coordinators and investigators on study activities and on the EDC platform used by the Company.
• Contribute to team efforts in drafting and editing of scientific manuscripts and conference posters including generation of figures tables and supporting analyses.
• Assist in writing and editing SOPs related to clinical data management and bioinformatics workflows.
• Comply with all company SOPs and safety standards.
• Perform other related duties as needed and required by supervisors.
• Maintain confidentiality of customer and patient information.

Minimum Qualifications:

• B.S. degree in bioinformatics data science biostatistics computer science or a related quantitative field and a minimum of 5 years of experience preparing managing and analyzing clinical or biological datasets in an academic or corporate setting; an advanced degree may substitute for up to 2 years of experience.
• Proficiency in Python and SQL for data manipulation quality control and analysis including reproducible workflows and version control.
• Demonstrated experience applying machine learning methods to biological clinical or other high-dimensional datasets.
• Working familiarity with modern AI tooling including practical experience with large language models.
• Interest in clinical research operations and willingness to develop working knowledge of ICH/GCP EDC platforms and clinical data management practices with mentorship.
• Must have excellent attention to detail and organizational skills.
• Must have good written and verbal communication skills.

Preferred Qualifications:

• M.S. or Ph.D. in a quantitative or life-science discipline.
• Experience supporting clinical trials including EDC platforms clinical data management practices and working knowledge of ICH and GCP.
• Experience in a CLIA-certified laboratory diagnostics or other regulated clinical environment.
• Experience with immunology autoimmune serologies or rheumatology-related clinical data.
• Familiarity with CDISC data standards R and cloud computing environments.
• Clinical research or clinical data management certification (e.g. SCDM CCDM) preferred but not required.

Pay Range: $130000 - $160000 / Annually