YOUR TASKS AND RESPONSIBILITIES

• Contribute to the definition of relevant research questions according to the integrated evidence plan applicable for/addressable by observational studies, addressing business challenges identified by GME leads or Evidence Leads or evidence generation teams
• With a high degree of epidemiological / pharmaco-epidemiological methods expertise design and execute observational studies in close collaboration with cross-functional groups (with a focus on methodologically more ambitious studies for authority acceptance, e.g. post-marketing safety and comparative effectiveness studies)
• Design and execution of observational studies in close collaboration with cross-functional groups. The focus is on conducting effectiveness/safety and comparative effectiveness (CES) and safety studies for marketed products and launch products in cardiorenal/heart failure
• Identify epidemiology methods, relevant data sources and assess utility/suitability for observational studies in collaboration with methodological experts and internal customer functions
• Provide epidemiological perspectives, expertise, and recommendations in identification and design of observational studies, hybrid (interventional/non interventional) studies such as pragmatic trials, studies incorporating multiple data sources linkages and digital tools, patient preferences, sophisticated analytics, etc.
• Serve as Bayer’s internal expert on epidemiological topics to address needs from a broad customer base, including but not limited to Research, Clinical Development, Regulatory Affairs, Pharmacovigilance, Market Access, and Commercial
• Provide input on epidemiological activities/studies relevant to benefit risk management plans (RMP), clinical development submissions, other drug development and regulatory-related activities
• Contribute to Partnerships initiatives for the identification and establishment of appropriate external research/methods groups/data sources, ensuring integrated evidence generation needs are met