Remote Epidemiologist

Beacon Hill

Boston Massachusetts

United States

Customer Service / Call Center
(No Timezone Provided)

Job Summary

One year contract to start


Fully remote


Duties: The Consultant Epidemiologist is a scientific role that involves supporting the development, coordination, and execution of cutting-edge, effective, and impactful research for rare disease epidemiology at a global level. The Consultant Epidemiologist will support the aHUS registry, especially analyses using registry data, and other hematology/nephrology indications. The Consultant Epidemiologist has accountability for supporting the development of Epidemiology Department deliverables to improve disease understanding supporting clinical development programs, regulatory submissions, and drug safety evaluations. The Consultant Epidemiologist will work closely with Director and Senior Director-level Epidemiologists in the Department and may represent the Epidemiology Department in cross-functional teams consisting of Clinical Development, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Health Economics and Outcomes Research, and Commercial. The Consultant Epidemiologist must have mature team-working behaviors with organizational awareness and insight. The Consultant Epidemiologist may work with Epidemiology Department leadership to interface with key senior management and external stakeholders to ensure appropriate communication of results from epidemiology deliverables. The ideal candidate will have prior experience with analysis and interpretation of epidemiologic data within the context of rare diseases and will be passionate about the application of epidemiology to support developing and delivering life-transforming therapies for patients.


Plan and execute analyses using aHUS registry data, collaborating with staff and CROs.


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 outcomes.


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.


The Consultant Epidemiologist may also participate in cross-functional team meetings for presentation of summary findings to internal/external stakeholders and support of Epidemiology Department processes and procedures



Skills:


At least 3 years of industry experience in the pharmaceutical industry, biotechnology, or consulting environment Strong analytical skills in conducting analyses using registry or secondary data Excellent oral and written communication skills Knowledge of drug and clinical development process Excellent attention to detail, 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


Education:


Master's Degree (MPH / MSc) in Epidemiology, Biostatistics, or relevant degrees



Remote Epidemiologist

Beacon Hill

Boston Massachusetts

United States

Customer Service / Call Center

(No Timezone Provided)

Job Summary

One year contract to start


Fully remote


Duties: The Consultant Epidemiologist is a scientific role that involves supporting the development, coordination, and execution of cutting-edge, effective, and impactful research for rare disease epidemiology at a global level. The Consultant Epidemiologist will support the aHUS registry, especially analyses using registry data, and other hematology/nephrology indications. The Consultant Epidemiologist has accountability for supporting the development of Epidemiology Department deliverables to improve disease understanding supporting clinical development programs, regulatory submissions, and drug safety evaluations. The Consultant Epidemiologist will work closely with Director and Senior Director-level Epidemiologists in the Department and may represent the Epidemiology Department in cross-functional teams consisting of Clinical Development, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Health Economics and Outcomes Research, and Commercial. The Consultant Epidemiologist must have mature team-working behaviors with organizational awareness and insight. The Consultant Epidemiologist may work with Epidemiology Department leadership to interface with key senior management and external stakeholders to ensure appropriate communication of results from epidemiology deliverables. The ideal candidate will have prior experience with analysis and interpretation of epidemiologic data within the context of rare diseases and will be passionate about the application of epidemiology to support developing and delivering life-transforming therapies for patients.


Plan and execute analyses using aHUS registry data, collaborating with staff and CROs.


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 outcomes.


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.


The Consultant Epidemiologist may also participate in cross-functional team meetings for presentation of summary findings to internal/external stakeholders and support of Epidemiology Department processes and procedures



Skills:


At least 3 years of industry experience in the pharmaceutical industry, biotechnology, or consulting environment Strong analytical skills in conducting analyses using registry or secondary data Excellent oral and written communication skills Knowledge of drug and clinical development process Excellent attention to detail, 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


Education:


Master's Degree (MPH / MSc) in Epidemiology, Biostatistics, or relevant degrees