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 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled