Clinical Business Analyst (for SDTM Automation)

Position: Clinical Business Analyst – SDTM Automation

Location: Remote, PST hours

Duration: 12+ Months

Job description:

Looking for Business Analyst (BA) acts as the bridge between clinical data managers, biostatisticians, and the automation engineering team. The primary ask from a Business Analyst is to translate complex clinical data standards and manual mapping workflows into clear, programmatic requirements for software developers. Here is a comprehensive breakdown of the specific deliverables, requirements, and responsibilities expected from a BA on this project:

1. Requirements Gathering & Process Mapping

• As-Is vs. To-Be Workflows: Map the current manual SDTM programming workflow (e.g., raw EDC data → Excel mapping specification → manual SAS programming) and define the optimized automated workflow.
• Automation Scope: Define exactly which parts of the lifecycle are being automated (e.g., auto-generating architecture, automated up-versioning from SDTM IG 3.2 to 3.4, or automated CDISC validation via Pinnacle 21 API).
• Source Data Ingestion: Specify the types of raw input data the system must handle (e.g., Rave EDC, Medrio, Labs, Biomarker vendors) and the expected formats (e.g., CSV, SAS7BDAT, JSON, CDISC ODM).

2. Functional & Technical Specification Authoring

• Metadata-Driven Rules: Define requirements for a centralized metadata repository where mapping rules (e.g., hardcoding, direct drops, conversions) are stored and read by the automation engine.
• Standard Domain Templates: Detail the functional requirements for automating standard, highly predictable domains (e.g., DM, TV, SV) versus complex, conditional domains (e.g., AE, CM, MH).
• Traceability & Lineage: Document requirements for the system to automatically generate compliance lineage—showing exactly how a raw variable transforms into an SDTM variable for regulatory auditing.

3. Data Governance & Regulatory Compliance

• CDISC Standards Alignment: Ensure the automation logic strictly adheres to CDISC SDTM Implementation Guides (SDTM IG) and Controlled Terminology (CT).
• Traceability Documents: Define how the system will auto-generate mandatory regulatory deliverables, specifically the Define.xml file and the Analysis Data Reviewer's Guide (cADRG) templates.
• GxP and Validation: Outline functional requirements for audit trails, electronic signatures (21 CFR Part 11 compliance), and user access controls.

4. User Acceptance Testing (UAT) & Business Readiness

• Test Case Generation: Write comprehensive UAT scripts containing diverse clinical scenarios (e.g., handling missing dates, partial dates, and split domains like FA).
• Parallel Run Strategy: Define the criteria for "parallel testing," where the automated pipeline's outputs are compared against manually programmed legacy SDTM datasets to calculate the accuracy rate.
• Change Management: Create training materials, user guides, and Standard Operating Procedures (SOPs) for data managers and programmers transitioning to the automated platform.