Senior Healthcare Business Analyst responsible for translating clinical, pharmaceutical, and patient-care requirements into Databricks Lakehouse data structures and business logic. The role maps EHR, laboratory, clinical trial, and genomic data; defines pipeline specifications; supports CDISC standardization; and ensures compliance with FDA 21 CFR Part 11, GxP, HIPAA, and privacy requirements. It also requires data quality, lineage, auditing, and collaboration with clinicians, researchers, biostatisticians, and engineering teams.
Job Title: Senior Healthcare Business Analyst
Type: Part Time
Experience Level: Senior
V4C.ai is currently seeking a highly skilled and experienced Senior Business Analyst to join our team. In this critical role, you will be responsible for bridging the gap between business objectives and technology solutions, ensuring that our projects align with organizational goals and deliver maximum value. You will utilize your expertise in business analysis and data-driven decision-making to identify opportunities for improvement and drive successful project outcomes.
A Senior Healthcare Business Analyst (Databricks Data Engineering – Clinical & Pharma) designs data structures and business logic to support clinical trials, drug development, and patient care workflows. They bridge the gap between clinical researchers, biostatisticians, and data engineering teams to transform unstructured EHR data and clinical trial outputs into a unified Databricks Lakehouse.
Core Responsibilities
- Clinical Data Elicitation: Partner with clinicians, researchers, and principal investigators to define data requirements for clinical registries, real-world evidence (RWE) studies, and therapeutic pipelines.
- Clinical Data Architecture Mapping: Map complex, disparate source data (EHR systems like Epic/Cerner, Lab Information Management Systems, eCRFs, and genomic data) into a standardized Databricks Medallion Architecture (Bronze, Silver, Gold layers).
- Pipeline & Standardization Logic: Translate complex clinical definitions (e.g., patient cohort inclusion/exclusion criteria) into functional specifications for data engineers using PySpark or Delta Live Tables.
- GxP & Regulatory Compliance: Ensure all data pipelines, storage, and processing environments comply with FDA 21 CFR Part 11, GxP (Good Practice) guidelines, HIPAA, and data privacy frameworks.
- CDISC Standardization Support: Oversee the transformation of raw operational data into industry-standard formats for regulatory submissions.
Technical Skills & Experience
- Clinical Data Standards: Deep operational knowledge of CDISC standards (SDTM, ADaM), OMOP Common Data Model (CDM), FHIR, HL7, SNOMED-CT, and LOINC.
- Databricks Environment: Strong working knowledge of Delta Lake, Unity Catalog (for managing clinical data access controls), and Databricks SQL dashboards.
- Languages & Tools: Advanced SQL proficiency to profile messy clinical data; ability to read and interpret Python/R code within Databricks notebooks used by data scientists.
- Data Auditing & Validation: Experience building data quality frameworks to track and audit data lineage from the patient bedside or lab bench to the final analytical dashboard.
Qualifications
- Experience: 10+ years as a Business Analyst, with 3+ years in data engineering environments and 5+ years specifically within the pharmaceutical, biotech, or clinical research sectors.
- Education: Bachelor’s or Master’s degree in Health Informatics, Biostatistics, Bioengineering, Computer Science, or a related field
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