RWD/RWE Strategist

vor 3 Wochen

Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit
Job Summary

We are seeking a highly skilled RWD/RWE Manager to join our Evidence Generation Department at PAUL HARTMANN AG. As a key member of our team, you will be responsible for designing and implementing RWD and RWE strategies to generate clinical, safety, and economic evidence for medtech products.

Key Responsibilities
  • Develop RWD and RWE Strategies: Design and implement RWD and RWE strategies to generate clinical, safety, and economic evidence for medtech products.
  • Collaborate with Cross-Functional Teams: Collaborate with cross-functional teams within the Evidence Generation Department and beyond to integrate RWE into product development and lifecycle management.
  • Lead Data Extraction and Analysis: Lead data extraction, cleaning, analysis, and interpretation from diverse real-world data sources such as electronic health records, claims data, patient registries, and wearables.
  • Communicate RWE Findings: Communicate RWE findings through reports, scientific publications, white papers, and presentations to internal stakeholders, regulatory authorities, and external audiences.
  • Ensure Regulatory Compliance: Ensure compliance with applicable regulatory guidelines and industry standards for data privacy, security, and ethical use of patient data.
Requirements
  • Advanced Degree: Advanced degree in epidemiology, biostatistics, health economics, public health, data science, or related fields.
  • Experience in RWD and RWE: 3+ years of experience in generating real-world data and evidence, preferably in medtech, pharma, or healthcare.
  • Proficiency in Statistical Programming: Proficiency in statistical programming and data analysis tools (SAS, R, Python) and familiarity with RWD platforms (e.g., Flatiron, IQVIA).
  • Strong Knowledge of RWE Study Designs: Strong knowledge of real-world study designs (retrospective cohort, case-control, registry-based) and global regulatory requirements (FDA, EMA).
  • Expertise in Data Privacy Laws: Expertise in GDPR, data privacy laws, and health economic models with evidence synthesis.
What We Offer
  • Flexible Working Conditions: Flexible working conditions, such as flexible working hours and mobile working.
  • Attractive Benefits: Attractive ways of combining work and family life, e.g. childcare subsidy, 30 days paid leave per year, company pension plan, and more.

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