Epidemiology Lead

Description

• Consult on/authoring of regulatory responses and participation in regulatory meetings related to safety or risk assessment.
• Safety epidemiology literature reviews supporting regulatory meetings, interactions, and submissions.
• Define the scope of the literature review. Depending on the scope, conduct the literature review or outsource to a literature review vendor. Manage the outsourced literature review (key contributor & approver of literature review protocol/literature review report; oversight of vendor(s); oversight & accountability for milestone deliverables & timelines).
• Background epidemiology studies, natural history of disease studies and user characterization studies.
• Post-approval safety studies that support regulatory meetings/interactions/submissions. Evaluate and explain regulatory needs.
• Share expert knowledge and experience with team to guide selection of design, data source & data collection methods proposed by vendor.
• Develop concept proposal with recommended design/potential data sources.
• Author regulatory response describing proposed study.
• Conduct technical feasibility assessment and operational feasibility assessments.
• Work to identify the study vendors and critically review the key deliverables from study vendors (protocol/protocol amendments, statistical analysis plan (SAP), draft interim/final reports/study results, major milestones, timelines).
• Manage the study (key contributor & approver of protocol/SAP/reports; responsible for key opinion leaders/expert interactions; responsible for regulatory responses; oversight of vendor(s); oversight & accountability for milestone deliverables & timelines).
• Participate in Risk Management Committee activities and apply epidemiologic methods to address safety and benefit/risk issues.
• Work collaboratively with key stakeholders internally and externally.

• Minimum required qualification is Master's degree in Epidemiology/Quantitative Public Health Discipline, with 2 years or more experience in the pharmaceutical industry, academia, and/or regulatory agencies.
• Understanding of the epidemiological analysis principles, experience with study design and implementation, experience conducting epidemiological literature reviews.
• Experience in applying epidemiologic methods to study the safety of medicines preferred.
• Understanding of and expertise in epidemiologic methods, including observational and experimental study designs and analysis.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects simultaneously.
• An understanding of drug development process, including regulatory aspects is a plus.
• Experience with statistical software packages (eg, SAS, SPSS or Stata).
• Knowledge of public and private epidemiologic resources and databases.
• Ability to collaborate effectively with experts from diverse disciplines.
• Sturdy/Site Monitoring experience.

SKILLS
Sturdy/Site Monitoring, Regulatory Experience

Synectics is an Equal Opportunity Employer.