Epidemiologist

San Rafael, CA 94901

Posted: 01/02/2019 Employment Type: Contract Industry: Medical Affairs Job Number: 5349

Our client  focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

 

Duties: 

Provide technical expertise in Epidemiology to develop and maintain a Real World Evidence strategy to support products from clinical development through licensing, market access, and lifecycle management. Specific activities include:
  • Participates in new drug development programs as a Subject Matter Expert (SME) in the areas of Real World Evidence & Epidemiology
  • Evaluation and monitoring of literature in therapy area as well as advancements in Epidemiology methods and policy/acceptance of Real World Evidence by regulators/payors
  • Critically appraise existing epidemiology evidence and create new evidence through delivery of specific research protocols and analysis of healthcare databases and prospective burden of illness studies
  • Improve disease understanding relevant to the target patient population: incidence, prevalence, risk factors, natural history disease course, burden of illness, treatment patterns, co-morbidities, co-medications, outcomes measures, phenotypes, biomarkers and unmet need, and their variations across demographics and geographies
  • Support post marketing activities: Conduct of post marketing post authorization safety studies and post marketing effectiveness studies/registries, epidemiology studies for safety signal detection, evaluation of risk mitigation strategies
  • Develop strong partnerships with internal stakeholders in a multi-disciplinary framework (Market Access, Medical Affairs, Clinical Development and Commercial functions) to support Real World Evidence needs
  • 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
  • Effectively communicate study findings to an internal and external audience base
  • Extend a track record of external publications in peer review journals and international congresses
  • Develop SOPs, guidelines, and templates to support conduct of Real World Evidence and Epidemiology studies

 

Skills:    

  • Demonstrated experience conducting pharmaco-epidemiologic research within or in support of the pharmaceutical industry
  • Self-motivated with the ability to work independently to develop credibility with colleagues, as well as interact effectively in multi-disciplinary matrix teams
  • Experience in collaborating with 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
  • Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings
  • Record of high quality, peer reviewed epidemiology or outcomes research publications preferred.
  • 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 Masters of Public Health in Epidemiology (MPH) (Preferred)
  • Clinical degree (ie. Medicine, pharmacy, nursing) and a master degree in Epidemiology with at least 5 years of experience leading epidemiologic research
  • 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
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