Principal Biostatistician FSP, RWE

About the role

DSSS, a unit within IQVIA, offers a Principal Biostatistician position for Real World Evidence (RWE) research as a Functional Service Provider (FSP). The role is home-based in the U.S. or Canada and provides full-range statistical support for drug development based on RWE. It is advertised as remote.

Key responsibilities

• Serve as statistical lead and represent Biometrics on health outcomes and epidemiology studies, and as subject matter expert for RWE/HEOR/HTA research design, methods, data sources, analytic techniques and reporting.
• Write statistical analysis plans and develop study protocols, analysis plans, reports and other study documents.
• Provide strategic and tactical support for cross-functional RWE development for regulators, payers and clinicians.
• Use administrative claims, electronic medical records, registries or other real-world data and recommend optimal analysis, selecting methods including statistical or machine learning models.
• Communicate with internal stakeholders on how and when to use real-world data, and maintain data accuracy and integrity through quality control.

Required profile

• Ph.D. in Statistics, Biostatistics or a related field with 5+ years of industry experience.
• Experience leading secondary data analysis (claims, EMR, chart reviews, registries) and as a project statistician with EMR/EHR and claims datasets.
• Fluency in LOA, mock TFLs, protocol writing and SAP.
• Experience in cost analysis and HCRU evaluation using real-world data, and with CDISC ADAM datasets.
• Extensive stakeholder experience with medical affairs and health economics.
• Preferred: understanding of payer landscape, health economic outcomes and value demonstration frameworks, exposure to regulatory submissions and HTA support, and R expertise.

Required skills

• In-depth knowledge of RWE databases (administrative claims, EMR, registries, clinical trial data).
• LOINC codes, reimbursement and lab data interpretation, and surrogate variable algorithms.
• Advanced SAS programming for complex analyses, inclusion/exclusion criteria, propensity score matching and outcome metrics.
• ICH GCP and E9, and global regulatory and HTA requirements for RWE.

What we offer

• Home-based remote work and flexible schedules.
• Technical training, research opportunities and a career trajectory.
• Long-term engagements and re-deployment opportunities.
• Focus on bringing therapies to market rather than project budgets.

The potential base pay range, annualized, is $111,000 to $309,000, depending on qualifications, location and schedule.