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Key Responsibilities:
• Prepare initial study concepts, including draft protocols and supporting documents, for internal scientific and statistical review committees
• Assist in creating and maintaining tracking tools, metrics, and reporting dashboards for real-world evidence (RWE) initiatives
• Participate in cross-functional groups focused on non-interventional research initiatives
• Provide input to internal subcommittees, program teams, and disease-focused groups where topics related to observational research, clinical burden, or natural history are evaluated
• Act as a representative for RWE in collaborative, cross-departmental efforts supporting development programs
• Apply effective communication approaches to explain and promote the use of real-world data (RWD) and RWE methodologies across different stakeholder groups
• Support dissemination efforts by contributing to abstracts, slide decks, and manuscripts for scientific meetings and peer-reviewed journals based on observational study outcomes
Basic Requirements:
• Doctoral degree in Epidemiology or a closely related discipline
• Demonstrated experience conducting epidemiologic or health services research across settings such as academia, industry, public sector, or consulting
• Formal academic training in epidemiology or health services research
• At least three years of hands-on experience with observational research in a life sciences, academic, governmental, or advisory environment
• Strong familiarity working with real-world data sources, including patient registries, administrative claims, and/or electronic health records
Preferred Experience:
• Prior experience working within a pharmaceutical or biotechnology organization
• Knowledge of regulatory frameworks such as the 21st Century Cures Act, particularly regarding the application of RWE in regulatory contexts
• Proven track record designing and implementing observational studies
• Excellent collaboration, communication, and project coordination abilities
• Skill in translating complex study findings into clear, audience-appropriate insights for non-technical stakeholders while preserving scientific accuracy
• Experience analyzing large healthcare datasets using tools such as SAS or R is advantageous
• Prepare initial study concepts, including draft protocols and supporting documents, for internal scientific and statistical review committees
• Assist in creating and maintaining tracking tools, metrics, and reporting dashboards for real-world evidence (RWE) initiatives
• Participate in cross-functional groups focused on non-interventional research initiatives
• Provide input to internal subcommittees, program teams, and disease-focused groups where topics related to observational research, clinical burden, or natural history are evaluated
• Act as a representative for RWE in collaborative, cross-departmental efforts supporting development programs
• Apply effective communication approaches to explain and promote the use of real-world data (RWD) and RWE methodologies across different stakeholder groups
• Support dissemination efforts by contributing to abstracts, slide decks, and manuscripts for scientific meetings and peer-reviewed journals based on observational study outcomes
Basic Requirements:
• Doctoral degree in Epidemiology or a closely related discipline
• Demonstrated experience conducting epidemiologic or health services research across settings such as academia, industry, public sector, or consulting
• Formal academic training in epidemiology or health services research
• At least three years of hands-on experience with observational research in a life sciences, academic, governmental, or advisory environment
• Strong familiarity working with real-world data sources, including patient registries, administrative claims, and/or electronic health records
Preferred Experience:
• Prior experience working within a pharmaceutical or biotechnology organization
• Knowledge of regulatory frameworks such as the 21st Century Cures Act, particularly regarding the application of RWE in regulatory contexts
• Proven track record designing and implementing observational studies
• Excellent collaboration, communication, and project coordination abilities
• Skill in translating complex study findings into clear, audience-appropriate insights for non-technical stakeholders while preserving scientific accuracy
• Experience analyzing large healthcare datasets using tools such as SAS or R is advantageous