Data Standards Specialist – SDTM, ADaM & Metadata

Project Role: Data Standards Specialist SDTM, ADaM & Metadata

Work Experience: 8+ years of relevant experience in Clinical Data Standards / Statistical Programming / Clinical Data Management

Work location: Any IQVIA office Location in India

Work Mode: Hybrid

Role Summary

The Data Standards Specialist is a Subject Matter Expert (SME) in CDISC SDTM, ADaM, and clinical metadata, responsible for defining, governing, and supporting standards-driven deliverables across studies. The role has a strong focus on aCRF PDF creation, SDTM/ADaM metadata curation, Pinnacle 21 Enterprise (P21E) exception management, and metrics support for Tables, Figures, and Listings (TFLs). This position ensures high-quality, compliant, and traceable data and metadata to support regulatory submissions and downstream analyses. The specialist works closely with Data Management, Statistical Programming, Biostatistics, Medical Writing, and sponsors to drive standardization, efficiency, and inspection readiness.

Key Responsibilities

1. Data Standards & Governance

• Serve as SME for CDISC SDTM and ADaM standards, including metadata and traceability principles.
• Develop, review, and maintain SDTM and ADaM specifications and metadata aligned with CDISC Implementation Guides and sponsor standards.
• Ensure consistent interpretation and application of standards across studies and programs.
• Lead standards governance activities such as standards reviews, impact assessments, and deviation management.

2. aCRF PDF Creation & Review

• Create, review, and maintain annotated CRF (aCRF) PDFs to support SDTM mapping and regulatory submissions.
• Ensure accurate and consistent annotation of CRFs to SDTM variables, domains, and controlled terminology.
• Collaborate with Data Management to align aCRFs with database design, CRF versions, and standards updates.
• Support submission-ready aCRF packages and address reviewer or regulatory queries related to annotations.

3. SDTM / ADaM Metadata Curation

• Curate, maintain, and govern study-level and standards-level SDTM and ADaM metadata.
• Ensure metadata consistency across SDTM, ADaM, Define.xml, aCRF, and TFLs.
• Support Define.xml / Define-XML 2.0 creation, review, and validation, with strong focus on metadata accuracy and traceability.
• Partner with programming and standards teams to enable metadata-driven study builds and automation initiatives.

4. Pinnacle 21 Enterprise (P21E) Exceptions Review

• Review, analyze, and manage Pinnacle 21 Enterprise (P21E) validation findings for SDTM and ADaM.
• Perform exception classification, justification, and documentation in alignment with sponsor and regulatory expectations.
• Guide teams on resolution strategies for errors, warnings, and notices.
• Ensure inspection-ready documentation for P21E exceptions and compliance decisions.

5. Metrics Support for TFLs

• Support the definition and review of standards and study-level metrics related to Tables, Figures, and Listings (TFLs).
• Ensure strong traceability from SDTM and ADaM to TFLs, including metadata alignment.
• Collaborate with Biostatistics and Statistical Programming to ensure consistent use of standards-driven metrics.
• Contribute to dashboards, reports, or summaries that track quality, compliance, and delivery metrics for TFLs.

6. Compliance & Quality

• Ensure datasets and metadata comply with regulatory submission requirements (FDA, PMDA, EMA, etc.).
• Support audit and inspection readiness activities related to data standards, metadata, and validation.
• Promote a strong quality mindset across teams, with focus on consistency, reusability, and traceability.

7. Cross-Functional Collaboration

• Partner with Data Management, Statistical Programming, Biostatistics, Medical Writing, and external vendors.
• Collaborate with sponsors to align on standards, metadata expectations, and submission strategies.
• Provide standards input during study start-up, database lock, analysis, and submission milestones.

8. Mentoring & Leadership

• Mentor junior team members on standards, metadata, and compliance best practices.
• Lead or contribute to training sessions and knowledge-sharing initiatives.
• Act as a reviewer/approver for complex standards, metadata, and validation deliverables.

Required Qualifications

Education

• Bachelors or Masters degree in Life Sciences, Statistics, Computer Science, or a related field

Experience

• 8+ years of hands-on experience with SDTM and ADaM
• Proven experience with aCRF creation/review, metadata curation, and P21E validation
• Experience supporting regulatory submissions
• Strong understanding of the end-to-end clinical data lifecycle

Technical Skills

• In-depth knowledge of:
• CDISC SDTM & ADaM Implementation Guides
• Controlled Terminology
• Metadata and traceability principles
• Hands-on experience with:
• Pinnacle 21 Enterprise (P21E)
• Define.xml / Define-XML 2.0
• Familiarity with standards and metadata tools
• Knowledge of R is an added advantage, especially for validation, analytics, or automation

Soft Skills

• Strong analytical and problem-solving abilities
• Excellent communication and stakeholder management skills
• Ability to work independently across multiple studies
• High attention to detail and quality mindset

Preferred Qualifications

• Experience in a global CRO or pharmaceutical environment
• Exposure to multiple therapeutic areas
• Experience with metadata-driven standards, automation, or governance frameworks
• Prior role as a Standards Lead or Standards SME