Principal Biostatistician FSP – Real World Evidence (RWE)
Location: Durham, North Carolina, United States
Employment Type: Full-Time
Requisition ID: R1454010
Work Model: Home-Based (U.S. or Canada; additional locations available)
Position Overview
IQVIA is seeking an accomplished Principal Biostatistician to support Real World Evidence (RWE) research through its Functional Service Provider (FSP) division, Data Sciences Staffing Solutions (DSSS). This role offers the opportunity to work fully embedded within leading pharmaceutical and biotechnology organizations, contributing to innovative real-world research that shapes the future of clinical development, regulatory science, and healthcare decision-making.
The Principal Biostatistician will provide strategic and technical statistical leadership across observational studies, HEOR initiatives, RWE analytics, and regulatory-/payer-focused research.
Why Join DSSS
Fully remote, home-based work environment.
Meaningful work-life balance with flexible scheduling.
Long-term career stability through extended FSP engagements and re-deployment opportunities.
Collaboration with high-performing biostatistics and epidemiology teams.
Access to technical training, custom development programs, and research opportunities aligned with your expertise.
Work focused on advancing therapies to market rather than managing project budgets or change orders.
Opportunities involving regulatory submissions.
Key Responsibilities
Serve as the statistical lead on health outcomes, epidemiology, and RWE studies, representing Biometrics across cross-functional teams.
Partner with project teams to define project goals, timelines, methodologies, and deliverables.
Provide strategic and technical expertise in RWE, HEOR, HTA research design, methodologies, data sources, and analytic frameworks.
Develop statistical analysis plans, study protocols, mock TFLs, and other key study documents.
Apply advanced analytical methods, including statistical modeling and machine learning approaches, aligned with study objectives.
Utilize claims, EMR, registry, and other RWD sources to design analyses and recommend optimal data-driven strategies.
Implement rigorous quality control processes to ensure accuracy, compliance, and integrity across all stages of data analysis.
Communicate analytical insights effectively to internal stakeholders, senior leadership, and external partners.
Identify innovation opportunities for enhancing RWE applications, methodologies, and analytical approaches.
Adapt efficiently to emerging project requirements and support ad-hoc analytical requests.
Required Knowledge, Skills, and Abilities
Extensive experience with RWE databases, including administrative claims, EMR/EHR, registries, and clinical data sources.
Proven expertise in designing and evaluating RWE from concept to delivery.
Strong knowledge of LOINC codes, lab data interpretation, surrogate endpoints, phenotype algorithms, and healthcare data structures.
Advanced ability to implement complex statistical analyses aligned with study goals.
Strong communication skills with the ability to present results to technical and non-technical audiences.
Solid understanding of ICH GCP, ICH E9, and general industry regulatory practices.
Knowledge of global regulatory and HTA requirements related to RWE.
Required Education and Experience
PhD in Statistics, Biostatistics, or related field with 5+ years of industry experience, or
Master’s degree in Statistics, Biostatistics, or related field with 7+ years of industry experience.
Demonstrated experience leading secondary data analyses using claims, EMR, chart review data, and registries.
Hands-on experience with major RWD sources such as Optum, MarketScan, CMS, Komodo, Truveta, TriNetX, and similar datasets.
Proven experience generating LOA documents, TFL shells, protocols, and SAPs.
Expertise in healthcare resource utilization (HCRU) and cost analyses using RWD.
SME-level proficiency in SAS for developing complex inclusion/exclusion criteria, propensity score matching, and outcome metrics.
Proficiency in R is highly valued.
Experience working with CDISC ADaM datasets.
Strong background collaborating with medical affairs and health economics teams.
Preferred but Not Required
Experience supporting HTA submissions or payer-focused evidence strategies.
Understanding of health economic outcomes, payer landscapes, and value demonstration frameworks.
About IQVIA
IQVIA is a global leader in clinical research, real-world evidence, analytics, and healthcare intelligence. Through innovative data-driven solutions, IQVIA accelerates the development and delivery of advanced medical therapies that improve patient outcomes and global public health.
Compensation
Annualized base salary range: USD 131,300 to 243,900.
Actual compensation is based on experience, education, skills, location, and employment schedule.
Incentive programs, bonuses, health and welfare benefits, and other forms of compensation may also be available.
Equal Opportunity Statement
IQVIA is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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