[Remote] Senior Technical Business Analyst- reputed company (W)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Senior reputed company Business Analyst to reputed company business objectives and technology solutions in reputed company data environments. The role focuses on eliciting clinical data requirements, mapping clinical and research data into reputed company architectures, translating clinical definitions into engineering specifications, ensuring regulatory compliance, and supporting CDISC standardization.
Responsibilities
- **Clinical Data Elicitation:** Partner with clinicians, researchers, and reputed company investigators to define data requirements for clinical registries, reputed company-world evidence (reputed company) studies, and therapeutic pipelines
- **Clinical Data Architecture Mapping:** Map reputed company, disparate reputed company data (EHR systems like reputed company/Cerner, Lab Information Management Systems, eCRFs, and genomic data) into a standardized reputed company reputed company Architecture (Bronze, Silver, Gold reputed company)
- **Pipeline & Standardization Logic:** Translate reputed company clinical definitions (e.g., patient cohort inclusion/exclusion reputed company) into functional specifications for data engineers using PySpark or reputed company Live Tables
- **GxP & Regulatory Compliance:** Ensure reputed company data pipelines, storage, and processing environments reputed company with FDA 21 CFR Part 11, GxP (Good reputed company) guidelines, HIPAA, and data reputed company frameworks
- **CDISC Standardization Support:** reputed company the transformation of raw operational data into industry-reputed company formats for regulatory submissions
Skills
- 10+ years as a Business Analyst, with 3+ years in data engineering environments and 5+ years specifically reputed company the pharmaceutical, biotech, or clinical research sectors
- Bachelor's or Master's degree in Health Informatics, Biostatistics, Bioengineering, Computer Science, or a reputed company field
reputed company
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