Remote Principal Biostatistician, RWE Research Lead

IQVIA LLC; Durham (NC); Remote; USD 120,000 - 309,000; Full time

Benefits offered by this job

Home-based remote work

Flexible schedules

Professional development

Job summary

IQVIA’s Data Sciences Staffing Solutions (DSSS) seeks a Principal Biostatistician to provide full statistical support for real-world evidence (RWE) drug development. This home-based role partners with sponsor teams, enabling flexible schedules while delivering rigorous analyses and regulatory-ready documentation.

You will lead statistical activities, oversee SAS programming for complex inclusion/exclusion criteria, and collaborate across cross-functional groups to drive strategic RWE initiatives.

Qualifications

• Ph.D. in Statistics, Biostatistics, or related field with 5+ years of industry experience.
• Experience leading secondary data analysis, including medical claims, EMR, registries.
• Hands-on experience as Project statistician with real-world data (EMR/claims).
• Fluency in LOA, mock TFLs, protocol and SAP.
• Experience in cost analysis and healthcare resource utilization (HCRU) using RWD.
• Experience with CDISC ADAM datasets.
• Extensive collaboration with medical affairs and health economics.

Responsibilities

• Collaborate with multi-disciplinary project teams to establish project goals and timelines.
• Serve as statistical lead and represents Biometrics on health outcomes and epidemiology studies.
• Serve as SME for RWE/HEOR/HTA research design, methodologies, data sources, and reporting.
• Write statistical analysis plans.
• Provide strategic/tactical support for cross-functional RWE development for regulators, payers, and clinicians.
• Leverage administrative claims, EMR, registries or other real-world data and recommend optimal analysis.
• Select and implement analytical methods including statistical models or ML models.
• Develop study protocols, SAS programs, study reports, and other study documents.
• Identify innovation opportunities for the use of RWD.
• Establish effective communication with internal stakeholders about using RWD.

Skills

SAS programming

RWE/HTA design

RWE data sources

ICH GCP/E9

Stakeholder communication

Project leadership

LOINC codes

Propensity score matching

Education

Ph.D. in Statistics/Biostatistics

Tools

SAS

Job description

IQVIA’s Data Sciences Staffing Solutions (DSSS) seeks a Principal Biostatistician to provide full statistical support for real-world evidence (RWE) drug development. This home-based role partners with sponsor teams, enabling flexible schedules while delivering rigorous analyses and regulatory-ready documentation.

You will lead statistical activities, oversee SAS programming for complex inclusion/exclusion criteria, and collaborate across cross-functional groups to drive strategic RWE initiatives.