Senior RWE Biostatistician
Fortrea
Job description
About the role
Fortrea is looking for an experienced Senior RWE Biostatistician within its Consulting business. You will deliver complex non-interventional and low-interventional Real-World Evidence (RWE) studies for global pharmaceutical and biotechnology companies, acting as a client-facing consultant. You will apply advanced biostatistical methods to claims databases, electronic health records, registries and linked data, and support regulatory, payer and HTA decision-making.
Key responsibilities
- Lead the design, analysis and interpretation of non-interventional and RWE studies using claims, EHR, registry and other real-world data sources.
- Apply causal inference and confounding-control methods such as propensity score matching and weighting, inverse probability weighting, instrumental variables, marginal structural models and difference-in-differences.
- Design evidence-generation strategies including target trial emulation, external control arms and synthetic controls.
- Develop and review Statistical Analysis Plans, protocol statistical sections, estimands and study design documentation.
- Align study methods and outputs with regulatory guidance and RWE frameworks, including FDA and EMA expectations.
- Perform statistical quality control and promote analytic reproducibility and transparency.
- Manage project teams, support proposals, budgets, bid defenses and business development, and contribute to publications and conferences.
- Mentor junior statisticians and analysts and act as a subject matter expert for RWE methodologies.
Required profile
- Advanced degree in Biostatistics, Statistics, Epidemiology, Health Economics, Data Science, Economics, Pharmacy or a related field (doctoral degree preferred).
- At least 6 years of biostatistics experience with a Master's degree, including non-interventional/RWE research, or 4 years with a doctorate.
- Proven experience leading statistical activities and client-facing projects in a CRO, pharma, biotech, healthcare or consulting setting.
- Experience with claims databases, EHRs, registries and OMOP-like data models; knowledge of causal inference, comparative effectiveness research and bias adjustment.
- Experience managing statisticians, analysts or project teams and mentoring others.
- Fluent business English, spoken and written.
Required skills
- SAS and R; Python experience is an advantage.
- Knowledge of regulatory expectations for RWE generation and evidence submissions.
What we offer
- Permanent employment contract with a competitive compensation package and local benefits such as pension contributions, health insurance and remote working allowance.
- Flexible working hours, a thorough onboarding with a personal mentor, and strong support from the line manager and team.
- Training, career development and support for continuing education.
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Published 20 hours ago
Expires 1 month from now
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Fortrea
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Fortrea