Clinical Data Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Configure and uphold EDC forms and eCRF specifications for data ingestion and subsequent analysis.

• Oversee comprehensive data management for Evidence Generation studies from ingestion to cleaning, quality control, and data lock.

• Develop, validate, and manage research databases.

• Create and execute data-cleaning workflows, which include queries, reconciliation, and audit trails.

• Extract, parse, and analyze EHR data from FHIR bundles, HL7v2 messages, and flat-file/CSV exports.

• Construct Python/SQL transformation pipelines that clean, standardize, and reshape raw EHR extracts into validated EDC-ready datasets.

• Implement field mapping, unit harmonization, deduplication, and derivation logic.

• Maintain reproducible, version-controlled transformation code.

• Design and manage data models for automated EHR-to-EDC ingestion.

• Collaborate with APIs/integration endpoints and harmonize diverse data models.

• Collaborate with site IT/informatics and Product teams regarding EHR constraints, extract structures, and change management.

• Translate EHR data realities into study data capture and monitoring plans.

• Develop and maintain Data Management Plans (DMPs), Statistical Analysis Plans (SAPs), Standard Operating Procedures (SOPs), runbooks, transformation/mapping specifications, and training materials.

• Conduct descriptive, comparative, and time-to-event statistical analyses.

• Utilize data-science techniques to derive features/cohorts, perform exploratory analysis, and assess data quality.

• Work collaboratively with stakeholders and train team members through SOPs, runbooks, and templates.

• Enhance EHR-to-Visualization-to-EDC auto-import pipelines and assist with sponsor-ready reporting.

⛳️ Requirements

• 5–7+ years of experience in clinical research/real-world evidence (RWE) data management, including hands-on database building and cleaning/quality control ownership.

• Proficiency in SQL and Python (or R) for data transformation, ETL pipeline development, quality control checks, and reproducible pipelines.

• Practical experience in transforming raw EHR extracts (FHIR, HL7v2, or flat-file exports) into structured, analysis/EDC-ready datasets.

• Familiarity with EHR or EHR-derived datasets.

• Knowledge of ICD-10, CPT, and LOINC; with RxNorm being preferred.

• Understanding of API-based ingestion and the integration of multiple data sources/models.

• Experience in creating and maintaining DMPs, SOPs, and runbooks.

• Proven experience with audit-ready documentation.

• Working knowledge of version control and reproducible pipeline practices, such as Git.

• Familiarity with the integration of leading AI techniques into work products.

• Experience with EDC platforms such as Medidata Rave, REDCap, Castor, or Veeva is preferred.

• Familiarity with CDISC (SDTM/ADaM) or equivalent standardization experience is preferred.

• Statistical experience in real-world/implementation studies is preferred.

• Experience with pipeline orchestration/data engineering tools and AWS data warehouses is preferred.

• Must be able to work in the United States without needing sponsorship, either now or in the future.

🏝️ Benefits

• Equity

• Performance-based bonus

• Medical insurance

• Dental insurance

• Vision insurance

• 401(k)

• Generous vacation

• Additional benefits for full-time employees

• Flexible remote work arrangement