RWE Strategy Lead

Pierre Fabre Group

. Define and drive the scientific strategy for real-world evidence generation for assigned products, indications or programs .

Posted 11/5/2026full-timeBoulogne-Billancourt • FranceSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in real-world evidence generation, including the design and implementation of observational studies and Integrated Evidence Generation Plans. Strong analytical skills and command of pharmacoepidemiology principles, with the ability to critically interpret complex analyses and communicate findings effectively.

Highest-signal resume keywords

Real-World Evidence GenerationObservational Study DesignIntegrated Evidence Generation PlansPharmacoepidemiology PrinciplesFit-for-Purpose Assessments

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Methodological DesignStatistical AnalysisData Source EvaluationComparative Study DesignAdvanced Analytical Skills

Soft Skills

Communication SkillsTeam CollaborationCritical Thinking

Tools & Technologies

Claims DataEHREMRDisease Registries

Certifications & Qualifications

Master's DegreePhD in EpidemiologyPharmacoepidemiology

Industry Keywords

Regulatory-Grade StudiesEMAFDAHealthcare DataPharmacoepidemiology Good Practices

About the role

Key responsibilities & impact

Define and drive the scientific strategy for real-world evidence generation for assigned products, indications or programs
Contribute to Integrated Evidence Generation Plans with R&D, Medical Affairs, HEOR, Regulatory, Biometry and other departments
Translate decision-making questions into relevant research questions
Lead methodological design of RWE studies, including population, exposure/intervention, comparator, endpoints, study period, bias and confounding control, sensitivity analyses and statistical approaches
Identify and select relevant real-world data sources
Conduct or oversee Fit-for-Purpose Assessments to evaluate data-source suitability
Develop expertise in assigned diseases, indications, standards of care, data sources, RWE methods and regulatory expectations
Ensure scientific rigor of protocols and oversee statistical analysis plans
Anticipate methodological limitations and define mitigation strategies
Critically interpret complex analyses in clinical, methodological and regulatory context
Produce scientifically robust conclusions and recommendations for decision-making
Disseminate results through reports, abstracts, posters, publications and other scientific materials
Support operational teams and external partners in faithful study implementation
Review and scientifically validate affiliate-initiated RWE studies
Build team capabilities by promoting good practices in pharmacoepidemiology and RWE

Requirements

What you’ll need

Master's degree or PhD in epidemiology, pharmacoepidemiology or public health, or medical doctor/pharmacist with significant experience in designing observational studies
Strong analytical and methodological skills
Demonstrated ability to design studies, apply advanced pharmaco-epidemiological approaches, and interpret and communicate complex analyses
Proven experience as Lead Author of observational study protocols, with direct and full responsibility for methodological design and protocol development
Experience primarily focused on project management or study operations does not meet the requirements
Demonstrated experience in the design and/or scientific conduct of comparative and/or regulatory-grade observational studies, particularly for the EMA or FDA
Demonstrated experience in the design and implementation of Integrated Evidence Generation Plans (IEGPs)
Hands-on experience with claims/administrative healthcare data, EHR/EMR and/or disease-specific registries, particularly from the United States, Europe or Asia
In-depth understanding of differences among real-world data sources and their collection methods
Ability to conduct or oversee Fit-for-Purpose Assessments (FFPA) and recommend study feasibility and data source selection
Command of pharmacoepidemiology principles, good practices and advanced methodological approaches
Ability to work with multidisciplinary profiles including clinicians, Medical Affairs, Regulatory, Safety/PV, HEOR, biostatisticians, data scientists and operational teams
Fluent spoken and written English
Seniority evidenced by concrete scientific and methodological achievements

Benefits

Comp & perks

Equal Employment Opportunity commitment
Reasonable accommodation for applicants with disabilities under the Americans with Disabilities Act and certain state or local laws
Equal consideration of all applications without discrimination