Principal Biostatistician – FSP, Real World Evidence (RWE)
Location: Remote (United States or Canada)
Job Type: Full-Time
Requisition ID: R1454010
Position Overview
IQVIA’s Data Sciences Staffing Solutions (DSSS) division is expanding and seeking a highly skilled Principal Biostatistician to support Real World Evidence (RWE) research through a Functional Service Provider (FSP) partnership. This home-based position offers the opportunity to work directly with leading pharmaceutical and biotechnology sponsors, contributing to evidence generation, regulatory strategy, and data-driven decision-making across global programs.
This role is ideal for experienced biostatisticians with deep expertise in RWE design, methodology, analytics, and the application of real-world datasets across healthcare research.
Key Responsibilities
Serve as the lead biostatistician on multidisciplinary RWE, HEOR, and epidemiology projects.
Provide strategic and methodological expertise in RWE research design, data sources, analytic techniques, and reporting.
Develop comprehensive Statistical Analysis Plans (SAPs) and study protocols.
Design and implement statistical and machine learning models aligned with project objectives.
Analyze real-world data, including administrative claims, EMR/EHR, registries, and large linked datasets.
Support regulatory, payer, and clinical evidence generation activities.
Produce high-quality study reports, technical documentation, datasets, and deliverables.
Identify opportunities for innovation in RWD methodology and applications.
Collaborate with cross-functional teams to optimize RWE strategy and data utilization.
Maintain rigorous data accuracy, integrity, and quality control across all study phases.
Respond effectively to evolving project requirements and ad-hoc analytic requests.
Required Knowledge, Skills, and Abilities
Expertise with RWE databases including administrative claims, EMR, registries, and clinical datasets.
Strong understanding of RWE development from concept to execution.
Familiarity with LOINC codes, lab data, reimbursement data, and clinical surrogate algorithms.
Ability to execute SAPs using advanced statistical programming techniques.
Strong communication skills for presenting research outputs internally and externally.
Knowledge of ICH GCP, E9 guidelines, and global RWE/HTA regulatory requirements.
Ability to oversee multiple complex projects simultaneously with precision and attention to detail.
Education & Experience Requirements
PhD in Statistics, Biostatistics, Epidemiology, or related field with 5+ years of industry experience,
OR
Master’s degree (MS) with 7+ years of relevant biostatistics experience.
Proven experience in secondary data analysis, including claims, EHR/EMR, registries, and chart review datasets.
Hands-on experience working with major RWD sources such as Optum, MarketScan, Humedica, CMS, Komodo, Truveta, or TriNetX.
Proficiency in SAS programming for complex data analyses (e.g., inclusion/exclusion logic, PSM, outcomes modeling).
Experience with R programming and CDISC ADaM datasets is beneficial.
Background collaborating with medical affairs, health economics, and payer strategy teams.
Demonstrated ability to design LOAs, mock TFLs, protocols, and SAPs.
Preferred Qualifications (Not Mandatory)
Familiarity with payer landscapes, value demonstration, and health economic outcome frameworks.
Exposure to regulatory submissions and HTA evidence packages.
Why Join IQVIA DSSS?
Home-based flexibility across the U.S. and Canada.
Opportunities to work with world-leading pharmaceutical and biotech organizations.
Long-term career stability with project redeployment support.
Strong work-life balance and flexible scheduling.
Access to technical training, professional development, and skill-aligned research engagements.
Fast-paced, collaborative environment focused on advancing new therapies to global markets.
Compensation
Estimated annual base salary range: USD 131,300 – USD 243,900.
Actual compensation is based on experience, qualifications, geographic location, and employment schedule. Additional benefits and incentive programs may apply.
Equal Opportunity Statement
IQVIA is committed to fostering an inclusive workforce. All qualified applicants will receive equal consideration without discrimination based on race, color, religion, sex, gender identity, national origin, disability, or protected veteran status.
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