Principal Statistical Programmer (Home-Based, United States)
Location: Durham, North Carolina (Home-Based Nationwide)
Job Type: Full-Time
Job ID: R1497090
IQVIA is seeking an experienced Principal Statistical Programmer to support our Functional Service Provider (FSP) team. This leadership role is ideal for senior programming professionals with advanced technical expertise, strong client-facing capabilities, and extensive experience across global clinical research and statistical programming environments.
The position is fully remote within the United States and involves leading the development, validation, and delivery of integrated programming solutions across diverse therapeutic areas including Oncology, Immunology, Infectious Diseases, and Early Development Clinical Phases (EDCP).
Role Purpose
The Principal Statistical Programmer will lead complex study deliverables, oversee programming activities, and serve as a technical expert within the statistical programming department. This role includes internal consulting, user needs assessment, and the creation of high-quality programming outputs that support clinical trial submissions and regulatory compliance.
Key Responsibilities
Advanced Programming & Study Deliverables
Lead programming, testing, validation, and documentation of statistical programs for tables, listings, and figures (TLFs).
Develop analysis datasets (ADaM) and SDTM datasets in alignment with CDISC standards.
Conduct quality control checks, identify data issues, and implement corrective actions.
Interpret project-level requirements and develop programming specifications for complex studies.
Technical Leadership & Team Management
Serve as the technical team lead for complex studies or a portfolio of studies.
Collaborate directly with statisticians, clinical teams, and global project stakeholders.
Provide training, mentoring, and guidance to statistical programming team members.
Coordinate resource planning, task assignments, and project timelines.
Client Interaction & Project Oversight
Act as the primary programming contact for clients on assigned projects.
Lead communication on project status, deliverable timelines, and technical requirements.
Estimate programming effort, negotiate timelines, and ensure consistent delivery of high-quality outputs.
Compliance & Best Practices
Apply GCP, ICH, and regulatory guidelines throughout all statistical programming activities.
Promote adherence to organizational standards, SOPs, and industry best practices.
Support process optimization and contribute to continuous improvement initiatives.
Required Experience & Skills
Experience Requirements
Minimum 7+ years of statistical programming experience in the CRO or pharmaceutical industry.
Proven experience leading programming teams and working directly with clients.
Strong background in Oncology, Immunology, Infectious Diseases, or related therapeutic areas.
Technical Expertise
Advanced proficiency in R programming and SAS (Base, Macro, STAT, Graph, SQL, ODS, ACCESS).
Deep understanding of SDTM and ADaM standards under CDISC.
Ability to execute advanced statistical procedures according to specifications from biostatisticians.
Strong understanding of relational databases and clinical trial data structures.
Regulatory Knowledge
Thorough understanding of ICH guidelines (E3, E6, E8, E9) and GCP requirements.
Solid knowledge of the clinical drug development lifecycle.
Soft Skills & Leadership
Strong organizational, leadership, and communication skills.
Ability to manage multiple concurrent projects independently.
High attention to detail, problem-solving capability, and decision-making skills.
Ability to establish and maintain professional relationships with colleagues, managers, and clients.
Education Requirements
Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field from a recognized institution.
Compensation
Annualized Base Pay Range:
Principal Statistical Programmer $88,300 – $294,800, depending on skills, experience, education, location, and work schedule.
Additional incentives, bonuses, and comprehensive health and welfare benefits may apply depending on the final offer.
About IQVIA
IQVIA is a global leader in advanced analytics, clinical research, and technology solutions for the life sciences sector. Through our integrated services, we support innovation, accelerate clinical development, and enhance patient outcomes worldwide.
IQVIA is an equal opportunity employer and provides consideration to all applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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