Position Title:
Principal Statistical Programmer – ADaM Standards, Oncology
Location:
Durham, North Carolina
(Home-based – available anywhere in the U.S. or Canada)
Job ID:
R1483331
Employment Type:
Full-Time | Home-Based | Sponsor-Dedicated Role
About the Role:
IQVIA is expanding a sponsor-dedicated programming team supporting the long-term data standards initiatives of a leading global pharmaceutical company.
As a Principal Statistical Programmer – ADaM Standards Engineer, you’ll act as the ADaM Standards Subject Matter Expert (SME) responsible for developing, maintaining, and implementing ADaM and CDISC standards across the sponsor’s portfolio.
This role focuses on standards development and management (not study-level programming) and requires strong Oncology experience, attention to detail, and a high degree of self-direction.
Key Responsibilities:
Develop, maintain, and enhance ADaM and SDTM standards, specifications, and TFL templates across therapeutic areas.
Support client-specific SDTM and ADaM mapping tools and standardization initiatives.
Review and provide feedback on e-submission packages for global regulatory authorities.
Lead study-related programming activities for specific molecules — writing ADaM specifications, performing and validating ADaM/TLF programming (safety & efficacy), and handling legacy data.
Review SDTM standards and assess the impact of updates on existing ADaM CORE standards.
Contribute to ADaM submission package reviews across multiple health authorities (FDA, EMA, PMDA).
Ensure ADaM datasets comply with CDISC and regulatory submission standards; maintain integrity and traceability.
Identify data inconsistencies and recommend corrective actions to ensure standards compliance and data quality.
Collaborate with Data Management teams to ensure proper data collection, CRF design, and transfer specifications aligned with submission standards.
Develop and maintain CDISC-related metadata libraries, controlled terminology, and standard repositories.
Provide governance oversight to ensure consistency in standards application.
Stay current on emerging regulatory data standards and evaluate their impact on data flows and submissions.
Act as a technical consultant to internal Data Sciences and project teams regarding standards implementation and compliance.
Qualifications:
Bachelor’s degree in Computer Science, Mathematics, Statistics, Biology, Pharmacology, or related discipline.
8+ years of experience as a Statistical Programmer, with demonstrated expertise in global data standards development and maintenance.
Proven experience in ADaM and SDTM implementation and regulatory submission requirements (FDA/PMDA/EMA).
Strong background in Oncology required; experience in Virology and/or Inflammation preferred.
Excellent problem-solving, communication, and collaboration skills.
Ability to work independently in a remote, high-accountability environment.
High attention to detail, multi-tasking capability, and strategic standards mindset.
Compensation:
Base Pay Range (Annualized): $88,300 – $273,200 USD
(Actual salary determined by experience, education, and location)
May include: bonuses, incentives, health, and welfare benefits
#LI-Remote | #LI-DNP
About IQVIA:
IQVIA is a global leader in clinical research, real-world evidence, and healthcare intelligence. We create intelligent connections between data, technology, and human science to accelerate the development of medical innovations and improve patient outcomes worldwide.
Learn more: https://jobs.iqvia.com
Equal Employment Opportunity:
IQVIA is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For details: https://jobs.iqvia.com/eoe
Apply Now:
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