Location: Boston, MA, full remote work preference for candidates from MA, CT, NY states
Our client is seeking an experienced Epidemiologist (Pharmaceutical) who will support the development, coordination, and execution of cutting-edge, effective, and impactful research for rare disease epidemiology at a global level, including deliverables to improve disease understanding supporting clinical development programs, regulatory submissions, and drug safety evaluations.
· Plan, support and execute analyses using the aHUS registry data and other hematology/nephrology indications, collaborating with internal staff and CROs.
· Work closely with Senior-level Epidemiologists in the Department and may represent the Epidemiology department in cross-functional teams.
· Work with Epidemiology Department leadership to interface with key senior management and external stakeholders to ensure appropriate communication of results from epidemiology deliverables.
· Summarize results in written reports and oral presentations.
· Support planning and execution of epidemiology deliverables relevant to drug development to characterize incidence and prevalence, time trends, co-morbidities, and co-medications.
· Systematic identification and critical appraisal of epidemiological literature to characterize incidence, prevalence, natural history, and phenotype/genotype associations.
· Oversee development of epidemiology sections of Regulatory, Pharmacovigilance, and Clinical Development documents, including Orphan Drug Applications, Risk Management Plans, PSURs/DSURs.
· Participate in cross-functional team meetings with presentation of summary findings to internal/external stakeholders and support development of Epidemiology department processes and procedures.
Skills and Qualifications
· Education: Master's Degree (MPH / MSc) in Epidemiology, Biostatistics, or relevant degrees
· At least 3 years of industry experience in the pharmaceutical industry, biotechnology, or consulting environment
· Knowledge of drug and clinical development process
· The ideal candidate will have prior experience with analysis and interpretation of epidemiologic data within the context of rare disease and will be passionate about the application of epidemiology to support developing and delivering life-transforming therapies for patients.
· Strong analytical skills in conducting analyses using registry or secondary data
· Excellent oral and written communication skills
· Excellent attention to detail and quality, and scientific rigor
· Ability to work under pressure and lead by example
· Strong interpersonal skills and ability to work effectively in multidisciplinary teams
· Thorough and up-to-date technical knowledge of epidemiology and biostatistics methods
· Must have mature team-working behaviors with organizational awareness and insight.
Interested candidate should email john@... their resume, target rate and how they match the requirements.
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John Barry ITech Consulting Partners
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