Associate Director, Real World Evidence

Job Description:

Location: 

remote,
United States

Category: Clinical

Employment Category: Fulltime-Temporary

Hiring Manager: Jeanne Pimenta (je903280@bmrn.com)

Description

Real World Evidence Lead (Associate Director) - Hybrid Role Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. About the role

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 novel 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 Biomarin products. This position will report to the Real World Evidence Product Lead.The Real World Evidence Leads are part of the Integrated Evidence 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 novel 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 Biomarin products. Key Responsibilities  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:

• 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
• Support post marketing activities including design and/or reporting of post marketing safety and effectiveness studies/registries, evaluation of risk mitigation strategies
• 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
• Designs secondary data analysis plans of BioMarin clinical and real-world data to support program strategy

• 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
• 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

 Desired Experience 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

 Skills

• Demonstrated experience conducting pharmaco-epidemiologic research within or in support of the pharmaceutical industry
• Experience in translating strategic evidence plans into scientific concepts in multiple protocols and ensuring they meet strategic program objectives 
• Ability to individually contribute to activities and projects based on guidance from Real World Evidence Product Lead
• Has independently authored protocol concept documents, study protocols and study reports
• Experience responding to regulatory agency, IRB/Ethics Committee questions regarding study designs and protocol conduct 
• 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 and collaborate 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