Description
DESCRIPTIONThe Epidemiology Lead will provide and carry out various Epidemiology group deliverables.
Responsibilities
- 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.