Manager, Oncology Epidemiology

About This Role

The Manager, Oncology Epidemiology will work independently and support the Oncology Epidemiology team, focusing on identifying research study needs, drafting protocols, and conducting epidemiology studies across clinical development programs. This role involves assisting with database assessments, conducting literature reviews, and providing epidemiological and statistical consulting to product teams.

Responsibilities

• Assist with identifying research study needs, drafting proposals and protocols, and contributing to epidemiology study conduct across the clinical development program.
• Assist with conducting fit for purpose database and study feasibility assessments and executing analyses across the product cycle.
• Conduct literature reviews and synthesis; provide assistance to senior epidemiologists and clinical teams with study design; and identify and evaluate data resources to meet therapeutic needs.
• Work closely with colleagues in the Observational Health Data Analytics group when defining research questions, developing epidemiological protocols, and implementing solutions.
• Provide epidemiological and/or statistical consulting, education and support to product teams, and assist with disseminating technical information through technical reports, presentation, and publication in peer-reviewed literature.
• Research natural history of diseases to understand inherent risks associated with indications, perform statistical risk assessment, and use historical data to understand potential safety issues for new medications.
• Keep up to date with the FDA and other Regulatory Agencies regarding regulatory requirements for Post Approval Authorization Studies and Risk Management plans and the development of formal guidance for use of RWE for Regulatory Decision Making.

Requirements

• PhD in Epidemiology or a closely related field OR MD with training and degree in Epidemiology or a closely related field OR Master’s degree with at least 2 years of hands-on experience
• At least 2 years of Epidemiology research experience
• Understanding and ability to interpret quantitative methods

Qualifications

• PhD in Epidemiology or a closely related field OR MD with training and degree in Epidemiology or a closely related field OR Master’s degree with at least 2 years of hands-on experience
• At least 2 years of Epidemiology research experience is required.

Nice to Have

• Experience with writing observational study protocols, proposals, and/or proposal requests, particularly methods sections
• Track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports)
• Experience working with large administrative or medical records databases
• Applied pharmacoepidemiology research
• Background in epidemiologic material on specific diseases, conditions, or therapies, particularly relating to the disease specific therapeutic area
• Experience working with health authorities
• Phase III/IV medicine development experience
• Experience working in a global environment

Skills

* Required skills

Benefits