RWD/ RWE Manager (f/m/d)

Responsibilities:

• Design and implement RWD and RWE strategies to generate clinical, safety, and economic evidence for medtech products
• Collaborate with cross-functional teams within Evidence Generation Department (Clinical Trials, Evidence Synthesis, Health Economics, and Diagnostic/Prognostic Research), and beyond, including regulatory, clinical affairs, market access, marketing, and sales to integrate RWE into product development and lifecycle management
• Develop study protocols, including observational studies, registries, and post-market surveillance, to gather and analyze real-world data
• Lead data extraction, cleaning, analysis, and interpretation from diverse real-world data sources such as electronic health records (EHR), claims data, patient registries, and wearables
• Communicate RWE findings through reports, scientific publications, white papers, and presentations to internal stakeholders, regulatory authorities, and external audiences
• Ensure compliance with applicable regulatory guidelines and industry standards for data privacy, security, and ethical use of patient data
• Stay up to date with emerging trends and technologies in real-world data and evidence generation, and apply innovative methods to optimize RWD and RWE strategies

Qualifications:

• Advanced degree in epidemiology, biostatistics, health economics, public health, data science, or related fields
• 3+ years of experience in generating real-world data (RWD) and evidence (RWE), preferably in medtech, pharma, or healthcare
• Proven experience with real-world data sources (EHR, claims, registry data) and RWE studies for regulatory or HTA purposes
• Proficiency in statistical programming and data analysis tools (SAS, R, Python) and familiarity with RWD platforms (e.g., Flatiron, IQVIA)
• Strong knowledge of real-world study designs (retrospective cohort, case-control, registry-based) and global regulatory requirements (FDA, EMA)
• Expertise in GDPR, data privacy laws, and health economic models with evidence synthesis
• Strong project management, communication skills, and experience in medtech or digital health solutions

Benefits:

• Flexible working conditions, such as flexible working hours and mobile working
• Attractive ways of combining work and family life, e.g. childcare subsidy
• 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement
• Company pension plan with attractive employer contribution incl. matching model for deferred compensation
• Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop
• Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass)
• Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc.
• Job Bike Leasing
• Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform

Location: Stadt Herbrechtingen, DE

Posted Date: 10/7/2024