IQVIA
life sciences and healthcare
SeniorStatisticalProgrammer
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Statistical Programmer at IQVIA. Skills: Metadata Repository (MDR) tools, metadata-driven transformation frameworks, CDISC standards (SDTM, ADaM, Define-XML), ADaM datasets, Tables, Listings, and Figures (TFLs). Work on Metadata Repository (MDR) tools supporting metadata authoring, versioning, publishing, and governance. Implement and manage metadata-driven transformation frameworks for SDTM/ADaM”
Industry & Context.
What They're Looking For.
Must Have
Metadata Repository (MDR) tools, metadata-driven transformation frameworks, CDISC standards (SDTM, ADaM, Define-XML), regulatory requirements (FDA, PMDA, EMA), GxP and regulatory validation standards (21 CFR Part 11)
Nice to Have
EDC platforms (e.g., Medidata Rave), third-party/vendor data integration, Data Transfer Specifications (DTS), validation and QC activities, double programming, dataset review, validation documentation, ADaM datasets, Tables, Listings, and Figures (TFLs)
What You'll Do.
Work on Metadata Repository (MDR) tools supporting metadata authoring
Implement and manage metadata-driven transformation frameworks for SDTM/ADaM
Ensure metadata consistency
and reusability across studies
Support MDR lifecycle activities including enhancements
and change control processes
Develop and validate datasets in compliance with CDISC standards (SDTM
Ensure adherence to regulatory requirements (FDA
Contribute to standardization efforts including controlled terminology and metadata standards
Collaborate with global teams to harmonize data standards across studies
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
Perform validation and QC activities including double programming and dataset review
Support validation documentation (test scripts
traceability matrices
Ensure compliance with GxP and regulatory validation standards (21 CFR Part 11)
Create and validate ADaM datasets as per Statistical Analysis Plan (SAP)
and Figures (TFLs) for clinical study reports
Support statistical analysis and regulatory submissions
How You'll Work.
Team & Collaboration
Collaborate with global teams to harmonize data standards across studies
Full Job Description
## **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 commer
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