Principal Statistical Programmer – ADaM Standards, Oncology
Location: Durham, North Carolina, United States
Employment Type: Full-Time
Requisition ID: R1483331
Work Model: Home-Based (United States or Canada; additional locations available)
Position Overview
IQVIA is seeking a highly experienced Principal Statistical Programmer with deep expertise in ADaM standards to support a sponsor-dedicated team within a leading global pharmaceutical organization. This strategic role focuses on standards governance, standards development, and the ongoing enhancement of ADaM and SDTM frameworks across a broad clinical portfolio.
This is not a study-level programming role; instead, it requires strong leadership, independent problem-solving, and advanced knowledge of CDISC standards, with an emphasis on Oncology therapeutic areas. Candidates must be highly self-directed, detail-oriented, and experienced in building, managing, and applying global clinical data standards.
Key Responsibilities
Lead development and maintenance of sponsor-specific clinical data standards, including SDTM and ADaM specifications and TFL standards across multiple therapeutic areas.
Support client-specific SDTM and ADaM mapping tools and ensure optimal application of standards.
Conduct reviews of e-submission packages and provide expert-level feedback.
Lead programming activities for legacy datasets at the molecule level, including specification, development, and validation of ADaM datasets and TLF outputs for safety and efficacy.
Develop, review, and maintain ADaM CORE standards and assess impacts of SDTM updates on ADaM frameworks.
Participate in ADaM submission package reviews across different global regulatory authorities.
Provide technical and operational expertise in applying clinical data standards (SDTM, ADaM, Define-XML) across the statistical programming workflow.
Identify data inconsistencies related to standards compliance and propose solutions that enhance data quality, review efficiency, and submission readiness.
Ensure study-level ADaM datasets comply with CDISC, regulatory, and client-specific requirements.
Collaborate with Data Management and study teams to develop data collection standards, CRF design elements, and external data strategies aligned with downstream SDTM/ADaM requirements.
Manage CDISC-related metadata libraries and terminology while ensuring consistent standards governance.
Monitor evolving regulatory requirements related to data standards and provide impact assessments and guidance to data science teams and project stakeholders.
Required Qualifications and Experience
Bachelor’s degree in Computer Science, Mathematics, Statistics, Biology, Pharmacology, or a related discipline.
Minimum 8+ years of experience as a Statistical Programmer, with recent experience supporting or developing global clinical data standards within a Sponsor or CRO environment.
Expert-level knowledge of CDISC SDTM and ADaM standards, as well as regulatory submission requirements for FDA, PMDA, and EMA.
Strong therapeutic area experience in Oncology is required; experience in Virology or Inflammation is an advantage.
Proven ability to lead standardization efforts across large portfolios and complex projects.
Excellent written and verbal communication skills with strong attention to detail and the ability to guide teams and stakeholders.
About IQVIA
IQVIA is a global leader in clinical research, advanced analytics, technology-driven insights, and healthcare intelligence. The organization supports the development and commercialization of innovative medical treatments that improve patient outcomes and global public health.
Compensation
Annualized base pay range: USD 88,300 to 273,200.
Actual compensation will vary based on qualifications, experience, geographic location, and employment schedule.
Additional benefits may include incentive programs, bonuses, health and welfare coverage, and other role-specific compensation packages.
Equal Opportunity Statement
IQVIA is an equal opportunity employer. All qualified applicants will receive consideration without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected category.
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