Remote Associate Director, Real World Evidence (Epidemiologist)
750 Lindaro Street San Rafael, CA 94903 US
Job Description
Duties
Implement observational research studies in-line with a product’s Integrated Evidence Plan under the guidance of a Real World Evidence Product Lead. Specific activities include:
- Protocol and statistical analysis plan 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
- Support post marketing activities including design, analysis plans and/or reporting of post marketing safety and effectiveness studies/registries, evaluation of risk mitigation strategies
- Develop and negotiate research plans with external collaborators in academia or contract research organizations and work effectively to oversee external groups through the research process
- Perform targeted literature review for incidence/prevalence of disease; work with commercial team on product forecasts and write regulatory documents including Orphan Drug Designation applications
- Evaluation and monitoring of literature in the therapy area
Skills
- Demonstrated experience conducting pharmaco-epidemiologic research within or in support of the pharmaceutical industry
- Self-motivated with the ability to develop credibility with colleagues and interact effectively
- Experience in collaborating with internal and external research partners
- Ability to work well in a business-driven environment, balance priorities and handle multiple tasks through careful planning, stakeholder management, project administration, and organizational skills
- Ability to individually contribute to activities and projects based on guidance from Real World Evidence Product Lead.
- Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings
- 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
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