Job Title:
Principal Biostatistician, Functional Service Provider (FSP) - Real World Evidence (RWE)
๐ Durham, North Carolina (Home-based in the U.S. or Canada)
๐ Full-Time
๐ Job ID: R1454010
๐ Job available in additional locations
Company Overview
IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. Data Sciences Staffing Solutions (DSSS) offers fully embedded resources through Functional Service Provider (FSP) partnerships, enabling collaboration with expert sponsor teams and access to world-class pharmaceutical and biotech clients.
๐ Learn more: https://jobs.iqvia.com
Why DSSS?
Home-based remote working opportunities
Work/life balance and flexible schedules
Collaborate with motivated, high-performance statistical and research teams
Access to technical training and tailored development programs
Research projects matching your unique skillset
Promising career trajectory with long-term engagement and redeployment opportunities
Focus on bringing new therapies to market rather than project budgets
Engaging, fast-paced work environment
Job Summary
Provide comprehensive statistical support for drug development programs using real world evidence (RWE).
Responsibilities
Collaborate with multidisciplinary teams to establish project goals and timelines
Serve as statistical lead representing Biometrics on health outcomes and epidemiology studies
Act as subject matter expert in RWE, HEOR, and HTA research design, methodologies, data sources, analytics, and reporting
Write and review statistical analysis plans
Provide strategic and tactical support for RWE development targeting regulators, payers, and clinicians
Utilize administrative claims, electronic medical records (EMR), registries, and other real-world data sources to recommend optimal analyses
Select and implement appropriate analytical methods including statistical and machine learning models
Develop high-quality study protocols, statistical analysis plans, study reports, and other documentation
Identify innovation opportunities for RWD use
Maintain effective communication with internal stakeholders to support RWD strategy
Ensure rigorous quality control to maintain data accuracy and integrity
Adapt quickly to new requirements and manage ad-hoc requests efficiently
Required Knowledge, Skills, and Abilities
Deep knowledge of RWE databases (claims data, EMR, disease registries, clinical trial data)
Proven experience conceptualizing and developing RWE studies
Familiarity with LOINC codes, reimbursement/lab data interpretation, and surrogate variable algorithms (phenotype definitions, proxies for clinical endpoints)
Ability to execute complex statistical analyses using advanced programming techniques
Effective communication of research results to both internal and external audiences
Understanding of ICH GCP, E9, and industry standards
Knowledge of global regulatory and HTA requirements for RWE
Education & Experience
PhD in Statistics, Biostatistics, or related field with 5+ years industry experience, OR
MS in Statistics, Biostatistics, or related field with 7+ years industry experience
Experience leading secondary data analysis involving medical claims, EMR/EHR, chart reviews, and registries
Hands-on project statistician experience with RWD datasets such as Humedica, Optum, MarketScan, CMS, Komodo, Truveta, TrinetX, etc.
Expertise in cost analysis and healthcare resource utilization (HCRU) evaluations using RWD
SME-level proficiency in SAS programming including complex inclusion/exclusion criteria, propensity score matching, and outcome metric development
Valued experience with R programming
Experience with CDISC ADaM datasets
Extensive experience collaborating with medical affairs and health economics stakeholders
Preferred but Not Required
Understanding of payer landscape, health economic outcomes, and value demonstration frameworks
Experience with regulatory submissions and HTA support
Compensation & Benefits
๐ฐ Annual Salary Range:
$131,300 – $243,900 (subject to variation based on qualifications, experience, location, and schedule)
Additional benefits may include:
Incentive plans and bonuses
Health and welfare benefits
Work Environment
๐ Home-based (Remote work) within the U.S. or Canada
Equal Employment Opportunity
IQVIA is an equal opportunity employer. All qualified applicants receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or other protected characteristics.
๐ EEO Policy
How to Apply
๐ Apply Now
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