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Principal Biostatistician Fsp, Rwe

5-7 years
$131,300 – $243,900 USD
10 Oct. 29, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.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

Position Title:

Principal Biostatistician – FSP, Real World Evidence (RWE)


Location:

Durham, North Carolina
(Home-based – open to candidates in the U.S. or Canada)


Job ID:

R1454010


Employment Type:

Full-Time | Home-Based | FSP Model


About the Role:

As a Principal Biostatistician within IQVIA’s Data Sciences Staffing Solutions (DSSS) unit, you’ll serve as a statistical leader supporting Real World Evidence (RWE) research. This role provides an opportunity to work with leading global pharmaceutical and biotech companies through IQVIA’s Functional Service Provider (FSP) partnership—combining the resources of a top-tier CRO with deep sponsor collaboration.

You’ll deliver advanced statistical expertise to design, analyze, and interpret RWE studies that influence global healthcare, regulatory, and payer decisions.


Why Join DSSS at IQVIA:

  • Home-based flexibility (U.S. or Canada)

  • Balanced workload and flexible schedules

  • Collaboration with high-performing statistical and RWE teams

  • Customized technical training and continuous career development

  • Long-term career stability and redeployment opportunities

  • Focus on scientific excellence over project billing or change orders

  • Opportunity to impact real-world treatment outcomes and regulatory submissions


Key Responsibilities:

  • Act as statistical lead on health outcomes and epidemiology projects.

  • Provide expert input on RWE/HEOR/HTA study design, data sources, analytic approaches, and reporting.

  • Develop statistical analysis plans (SAPs) and contribute to study protocols and technical documents.

  • Recommend and implement optimal analytical methods including statistical or machine learning models.

  • Leverage administrative claims, EMR, registries, and other real-world datasets to drive insights.

  • Generate high-quality outputs (protocols, SAPs, reports, TFLs, etc.).

  • Ensure compliance with data integrity, accuracy, and GCP/E9 guidelines.

  • Communicate results clearly to internal and external stakeholders.

  • Identify innovation opportunities for integrating real-world data into research strategies.

  • Lead multiple concurrent studies while ensuring timely delivery and scientific rigor.


Required Knowledge, Skills, and Abilities:

  • Expert knowledge of RWE data sources (claims, EMR, registries, clinical data).

  • Proven track record in RWE study conceptualization to execution.

  • Familiarity with LOINC codes, reimbursement data, surrogate variable algorithms, and phenotype definition methods.

  • Strong statistical programming expertise in SAS (including PSM, outcome metrics, and data derivation).

  • Proficiency in R preferred for advanced modeling.

  • Understanding of global regulatory and HTA evidence requirements.

  • Strong analytical, communication, and organizational skills.

  • Ability to work independently in a remote, fast-paced environment.


Education and Experience Requirements:

  • Ph.D. in Statistics, Biostatistics, or related field with 5+ years of industry experience, OR

  • M.S. in Statistics, Biostatistics, or related field with 7+ years of experience.

  • Experience in secondary data analysis (claims, EMR/EHR, registries, chart reviews).

  • Hands-on experience with RWD sources such as Humedica, Optum, MarketScan, CMS, Komodo, TrinetX, or Truveta.

  • Proficient in protocol/SAP development and mock TFL generation.

  • Exposure to cost analyses and HCRU (Healthcare Resource Utilization) assessments.

  • Experience collaborating with medical affairs and health economics stakeholders.

  • Experience with CDISC ADaM datasets is a plus.


Preferred but Not Required:

  • Familiarity with payer landscapes, HEOR methodologies, and value demonstration frameworks.

  • Experience supporting regulatory submissions or HTA assessments.


Compensation:

  • Base Pay Range (Annualized): $131,300 – $243,900 USD
    (Exact salary determined by experience, skills, education, and location)

  • Additional opportunities: bonuses, incentive plans, health and welfare benefits


#LI-Remote | #LI-NITINMAHAJAN


About IQVIA:

IQVIA is a global leader in clinical research, healthcare analytics, and life sciences intelligence.
We create intelligent connections that accelerate medical innovation, optimize healthcare, and improve patient outcomes worldwide.

Learn more: https://jobs.iqvia.com


Equal Employment Opportunity:

IQVIA is an Equal Opportunity Employer.
All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For details: https://jobs.iqvia.com/eoe


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