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Principal Biostatistician, Functional Service Provider (Fsp) - Real World Evidence (Rwe)

5 years
$131,300 โ€“ $243,900
10 Sept. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Principal Biostatistician, Functional Service Provider (FSP) - Real World Evidence (RWE)
๐Ÿ“ Durham, North Carolina (Home-based in the U.S. or Canada)
๐Ÿ•’ Full-Time
๐Ÿ“„ Job ID: R1454010
๐ŸŒ 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.

๐ŸŒ 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

๐Ÿ’ฐ 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

๐Ÿ  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.

๐Ÿ”— EEO Policy


How to Apply

๐Ÿ”— Apply Now