Principal Biostatistician FSP, RWE (Real-World Evidence)

Location: Home-based remote role in the United States or Canada

Annual base pay: $111,000–$309,000

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Provide statistical support for drug development based on real-world evidence.
• Lead Biometrics activities for health outcomes and epidemiology studies.
• Design RWE, HEOR, and HTA studies using claims, EMR, registry, and other real-world data.
• Write protocols, statistical analysis plans, study reports, and related study documents.
• Select and implement statistical and machine learning models, including propensity score methods and outcome metrics.
• Collaborate with multidisciplinary stakeholders and support RWE strategies for regulators, payers, and clinicians.

Requirements

• Ph.D. in Statistics, Biostatistics, or a related field and 5+ years of industry experience.
• Hands-on experience leading secondary data analyses using medical claims, EMR/EHR, chart reviews, and registries.
• Advanced SAS programming skills for complex inclusion and exclusion criteria, propensity score matching, and outcome metrics.
• Strong knowledge of RWE databases, LOINC codes, reimbursement and laboratory data, surrogate variable algorithms, and healthcare resource utilization.
• Experience developing LOA, mock TFLs, protocols, and statistical analysis plans, as well as working with CDISC ADaM datasets.
• Knowledge of ICH GCP, E9, global regulatory and HTA requirements, and experience collaborating with medical affairs and health economics stakeholders.

Nice to have

• Understanding of payer landscapes, health economic outcomes, and value demonstration frameworks.
• Experience with regulatory submissions and HTA support.
• Expertise in R programming.

Culture & Benefits

• Home-based remote work with flexible schedules and work-life balance.
• Collaboration with statistical, research, and sponsor teams through an FSP partnership.
• Technical training and a tailored development curriculum.
• Long-term engagements, career development, and potential redeployment opportunities.
• Opportunities to contribute to regulatory submissions and the development of new therapies.