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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in statistical leadership for Real-World Evidence (RWE) studies, with strong capabilities in SAS programming, statistical analysis, and compliance with quality standards. Proven ability to collaborate across cross-functional teams and manage stakeholder communications effectively.
Highest-signal resume keywords
Statistical LeadershipSAS ProgrammingReal-World Evidence (RWE)Statistical Analysis Plans (SAPs)Stakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
StatisticsStatistical ProgrammingSample Size CalculationsStatistical MethodologiesQuality ControlStatistical AnalysisProgramming ValidationData Analysis DatasetsEHR/EMRLarge Healthcare Databases
Soft Skills
Excellent CommunicationCollaborationStakeholder Management
Certifications & Qualifications
Master’s Degree in StatisticsMaster’s Degree in BiostatisticsMaster’s Degree in Epidemiology
Industry Keywords
PharmaceuticalBiotechHealthcareNon-Interventional StudiesSecondary Use of Data (SUD)Clinical Study Reports (CSRs)ETMF
About the role
Key responsibilities & impact- Provide statistical leadership for Real-World Evidence (RWE), non-interventional, and Secondary Use of Data (SUD) studies
- Review study synopses and protocols, including sample size calculations, study design, endpoints, and statistical methodologies
- Oversee external service providers’ statistical deliverables, including Statistical Analysis Plans (SAPs), TFLs, and interim analyses
- Monitor study statistical milestones and operational progress through vendor dashboards
- Ensure timely delivery of statistical outputs and analysis datasets in compliance with Ipsen quality standards
- Perform quality control of statistical analyses, including SAS programming and programming validation activities
- Review clinical study reports (CSRs) and external communications related to study results and analyses
- Collaborate with Biometry, Clinical Operations, Medical teams, and external partners
- Maintain complete and accurate study documentation, including accountability for eTMF completion
Requirements
What you’ll need- Master’s degree in Statistics, Biostatistics, Epidemiology, or a related scientific discipline
- Very strong experience in statistics and statistical programming within the pharmaceutical, biotech, or healthcare industry
- Significant exposure to Real-World Evidence (RWE), non-interventional studies, and Secondary Use of Data (SUD) projects
- Hands-on experience with SAS programming and statistical validation
- Experience with R and/or large healthcare databases (claims databases, EHR/EMR, registries) is considered a strong asset
- Excellent communication and stakeholder management skills
- Ability to collaborate effectively in a cross-functional and international environment
- Fluent English, both written and spoken
Benefits
Comp & perks- Opportunity to join a young and ambitious healthcare company with 900 employees
- Diverse and stimulating projects through a one-stop provider service model combining full-service, functional service provider, and consulting
- Collaboration with leading experts
- Opportunities to contribute to scientific, operational, and human knowledge
- Environment valuing natural talents, encouraging boldness, pushing boundaries, and cultivating potential
- Inclusive environment supporting collaboration and individual growth