Real World Evidence Lead (Associate Director)

Duties

This is a hybrid role within the Medical Evidence Generation function, which consists of subject matter experts in evidence planning, study design, and data interpretation. The role involves:

• Implementing real world evidence study solutions in-line with a product's Integrated Evidence Plan under the guidance of a Real World Evidence Product Lead.
• Developing protocols and reporting on disease understanding studies (retrospective and prospective) relevant to the target patient population, including risk factors, natural history, burden of illness, treatment patterns, co-morbidities, co-medications, outcomes measures, and unmet need.
• Supporting post-marketing activities, including the design and/or reporting of post-marketing safety and effectiveness studies/registries, and evaluating risk mitigation strategies.
• Collaborating with external partners in academia or contract research organizations to implement research plans and oversee external groups through the research process.
• Designing secondary data analysis plans of clinical and real-world data to support program strategy.
• Performing targeted literature reviews on the epidemiology of disease, including incidence/prevalence and treatment patterns.
• Working with the commercial team on product forecasts and writing regulatory documents, including Orphan Drug Designation applications.
• Analyzing raw data sets to conduct feasibility analyses and delivering tables/listings/graphs from in-house or licensed real-world datasets promptly.

Skills

• Demonstrated experience conducting pharmaco-epidemiologic research within or in support of the pharmaceutical industry.
• Understanding of statistical and data analysis, research methods, and design.
• Experience with real world data analysis (e.g., EHR, claims, and registry) supporting RWE/pharmacoepidemiology studies, including statistical programming skills (SAS, Python, or R).
• Knowledge of healthcare data standards (e.g., HL7, FHIR), medical terminologies used in healthcare data (e.g., ICD10), EMRs, and regulations (HIPAA, GDPR) is preferred.
• Ability to work in a business-driven environment, balance priorities, and handle multiple tasks through careful planning, stakeholder management, project administration, and organizational skills.
• Self-motivated with the ability to develop credibility with colleagues and interact effectively.
• Ability to individually contribute to activities and projects based on guidance from the Real World Evidence Product Lead.
• Experience in collaborating with internal and external research partners.
• Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence.
• Experience in the Epidemiology of rare diseases or Genetic Epidemiology is a benefit.

Education

A combination of academic training and practical experience in Epidemiology is required. This may consist of:

• Doctoral degree (PhD, ScD, or DrPH) or Master's of Public Health in Epidemiology and at least 2 years of experience leading epidemiologic research in the pharmaceutical setting.
• Doctoral degree (PhD, ScD, or DrPH) or Master's degree in a relevant discipline (i.e., Health services research, health outcomes research, public health, statistics, or pharmaceutical sciences) with at least 5 years of experience leading epidemiologic research in the pharmaceutical setting.