Clinical data management programmer Jobs

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Senior Statistical Programmer

IQVIA -
Telangana

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Job details

Full-time

Qualifications

Full job description

Telangana, India | Full time | Home-based | R1542408

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.

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Senior Statistical Programmer

Biostatistical Programming Manager

Sr Mgr Data Engineer

Statistical Programmer

Senior Validation Specialist

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Key Responsibilities

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

2. CDISC Standards Implementation (Must Have)

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

4. Validation / Quality Control (Good to Have)

5. ADaM & TFL Development (Good to Have)

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