Job Details

Job Title: Real World Evidence Lead
Duration: 12 months
Location: San Rafael, CA (Hybrid)

The Real World Evidence Leads are part of the Medical Evidence Generation function comprised of subject matter experts in evidence planning, study design and data interpretation. The function works to drive excellence in evidence planning and implement Client study design approaches to generate robust evidence to enhance understanding of unmet medical need; support patient and endpoint selection for Clinical studies; and inform clinical practice on appropriate use and long-term safety and effectiveness of Client products. This position will report to the Real World Evidence Product Lead.

Duties

Implement real world evidence study solutions studies in-line with a product's Integrated Evidence Plan under the guidance of a Real World Evidence Product Lead. Specific activities include:

1. Protocol development and reporting of 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.
2. Support post marketing activities including design and/or reporting of post marketing safety and effectiveness studies/registries, evaluation of risk mitigation strategies.
3. Support implementation of research plans with external collaborators in academia or contract research organizations and work effectively to oversee external groups through the research process.
4. Design secondary data analysis plans of Client clinical and real-world data to support program strategy.
5. Perform targeted literature review of epidemiology of disease, including incidence/prevalence and treatment patterns; work with commercial team on product forecasts and write regulatory documents including Orphan Drug Designation applications.
6. Analyze raw data sets to conduct feasibility analyses and deliver tables/listings/graphs from in-house or licensed real world datasets in a timely manner.

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 (combination of education and work) 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 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 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 (ie. 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.