Principal Statistical Programmer – ADaM Standards (Oncology)
Location: Remote, United States or Canada | Full-Time**
Requisition ID: R1483331
About the Role
IQVIA is seeking a highly experienced Principal Statistical Programmer specializing in ADaM Standards to support a sponsor-dedicated team within a leading global pharmaceutical organization. This is a fully home-based role open to candidates across the United States and Canada.
This position focuses on developing, maintaining, and implementing global clinical data standards, specifically SDTM and ADaM, with a strong emphasis on Oncology therapeutic areas. The role requires excellent problem-solving skills, independent work habits, and the ability to collaborate effectively with cross-functional teams.
Please note: This is a standards-focused role and does not involve direct study-level programming.
Key Responsibilities
Lead the development and maintenance of sponsor-specific clinical data standards, including SDTM and ADaM specifications and TFL frameworks across therapeutic portfolios.
Support and enhance sponsor-defined SDTM and ADaM mapping tools.
Provide expert review of e-submission packages and deliver high-quality feedback.
Lead programming activities for assigned molecules, including ADaM specification development and validation for both efficacy and safety, primarily using legacy data.
Maintain and update ADaM standards and assess impacts of SDTM standard updates on existing ADaM frameworks.
Participate in cross-authority ADaM submission package reviews.
Provide operational and technical support in implementing CDISC standards (SDTM, ADaM, DEFINE) across programs and submissions.
Identify data inconsistencies, recommend solutions, and ensure alignment with CDISC, regulatory, and protocol requirements.
Collaborate with Study Leads and Data Management to ensure accurate data collection standards, DTAs, CRF elements, and external data integrations.
Develop and maintain clinical metadata libraries, controlled terminology, and CDISC-related standards.
Monitor and interpret emerging regulatory requirements related to data standards and submissions; provide strategic recommendations to cross-functional teams.
Qualifications & Experience Required
Bachelor’s degree in Computer Science, Mathematics, Statistics, Biology, Pharmacology, or related field.
Minimum 8 years of industry experience as a Statistical Programmer.
Recent experience developing Global Standards within a Sponsor or CRO environment is essential.
Expert-level knowledge of CDISC SDTM and ADaM standards and global regulatory submission requirements (FDA, EMA, PMDA).
Strong therapeutic experience in Oncology; experience in Virology or Inflammation is an added advantage.
Proven ability to design, review, and maintain complex standards frameworks.
Excellent communication, documentation, and cross-functional collaboration skills.
About IQVIA
IQVIA is a global leader in clinical research services, advanced analytics, and healthcare intelligence. The organization accelerates the development and commercialization of innovative therapies to improve patient outcomes and population health globally.
Learn more at the official careers page.
Compensation
The anticipated annual base salary range for this role is USD 88,300 – USD 273,200. Actual compensation may vary based on qualifications, experience, geographic location, and employment schedule. Additional benefits may include incentive plans, bonuses, and health and welfare programs.
Equal Opportunity Employer
IQVIA is committed to creating an inclusive workforce. All qualified applicants will receive equal consideration without regard to race, color, religion, sex, gender identity, national origin, disability, or veteran status.
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