Senior Statistical Programmer

Key Responsibilities

1. Metadata Repository & Metadata-Driven Transformation (Must Have)

• Work on Metadata Repository (MDR) tools supporting metadata authoring, versioning, publishing, and governance
• Implement and manage metadata-driven transformation frameworks for SDTM/ADaM
• Ensure metadata consistency, traceability, and reusability across studies
• Support MDR lifecycle activities including enhancements, UAT, and change control processes

2. CDISC Standards Implementation (Must Have)

• Develop and validate datasets in compliance with CDISC standards (SDTM, ADaM, Define-XML)
• Ensure adherence to regulatory requirements (FDA, PMDA, EMA)
• Contribute to standardization efforts including controlled terminology and metadata standards
• Collaborate with global teams to harmonize data standards across studies

3. EDC & Third-Party Data Management (Good to Have)

• Work with EDC platforms (e.g., Medidata Rave) for clinical data acquisition
• Handle third-party/vendor data integration and mapping to CDISC standards
• Support creation and maintenance of Data Transfer Specifications (DTS) and external data flows

4. Validation / Quality Control (Good to Have)

• Perform validation and QC activities including double programming and dataset review
• Support validation documentation (test scripts, traceability matrices, UAT execution)
• Ensure compliance with GxP and regulatory validation standards (21 CFR Part 11)

5. ADaM & TFL Development (Good to Have)

• Create and validate ADaM datasets as per Statistical Analysis Plan (SAP)
• Develop Tables, Listings, and Figures (TFLs) for clinical study reports
• Support statistical analysis and regulatory submissions