Senior RWE Biostatistician

• Advanced degree in a relevant discipline such as Biostatistics, Statistics, Epidemiology, Health Economics, Data Science, Economics, Pharmacy, or a related field (Doctoral degree preferred)
• Minimum of 6 years of biostatistics experience with a Master's degree, including non-interventional/RWE research experience, or at least 4 years with a doctoral degree
• Proven experience leading statistical activities and delivering client-facing projects within a CRO, pharmaceutical, biotechnology, healthcare, or consulting environment
• Demonstrated expertise in applying biostatistical methods to RWE, epidemiology, and HEOR studies
• Experience utilizing real-world data sources such as claims databases, EHRs, registries, and OMOP or similar data models
• Strong understanding of causal inference, comparative effectiveness research, and bias-adjustment methodologies
• Experience developing SAPs, contributing to protocol design, statistical analysis, and reporting
• Programming proficiency in SAS and R (Python experience is considered an advantage)
• Knowledge of regulatory expectations and industry standards for RWE generation and evidence submissions
• Experience managing statisticians, analysts, or project teams and mentoring less experienced team members
• Strong client engagement, communication, presentation, and stakeholder management skills
• Excellent problem-solving ability, scientific curiosity, and attention to detail
• Business fluency in English, both verbal and written

As an experienced Senior RWE Biostatistician within our Consulting business, you will play a pivotal role in delivering complex Real-World Evidence (RWE), non-interventional, and low-interventional research studies for leading global pharmaceutical and biotechnology companies. Working as a trusted client-facing consultant, you will help design innovative evidence-generation strategies, lead statistical analyses, and provide scientific expertise that supports regulatory, payer, and health technology assessment (HTA) decision-making.

In this role, you will apply advanced biostatistical methodologies to real-world data sources including claims databases, electronic health records (EHR), registries, and linked data assets. You will contribute to the design, execution, and interpretation of high-impact studies while supporting business development activities, scientific publications, and internal innovation initiatives.

Your expertise will directly contribute to generating evidence that shapes healthcare decisions and improves patient outcomes worldwide. Join Fortrea and discover why more than 90% of the top 20 global pharmaceutical companies are repeat customers.

• Lead the design, analysis, and interpretation of non-interventional and RWE studies utilizing claims, EHR, registry, and other real-world data sources
• Apply advanced causal inference and confounding-control methodologies including propensity score matching and weighting, inverse probability weighting, instrumental variable methods, marginal structural models, and difference-in-differences approaches
• Design and support innovative evidence-generation strategies, including target trial emulation, external control arms, and synthetic control methodologies
• Develop and review Statistical Analysis Plans (SAPs), statistical sections of protocols, estimands, and study design documentation
• Ensure alignment of study methodologies and outputs with applicable regulatory guidance and RWE frameworks, including FDA and EMA expectations
• Perform statistical quality control and promote analytic reproducibility and transparency across client engagements
• Deliver strategic, scientific, and methodological expertise to clients and project teams
• Manage project teams responsible for statistical deliverables while providing guidance, oversight, and mentorship
• Support proposal development, budgeting, bid defenses, capability presentations, and other business development activities
• Contribute to internal innovation initiatives, methodological best practices, scientific publications, and conference presentations
• Mentor and develop junior statisticians and analysts through coaching, training, and performance feedback
• Act as a subject matter expert for RWE methodologies and statistical best practices across the organization