Epidemiologist / Sr Mgr Drug Safety & Public Health
You will lead the design, execution, and reporting of observational studies to support drug safety and public health initiatives.
Responsibilities
- Plan observational studies and draft protocol synopses, concept sheets, and full protocols.
- Determine study design criteria, including source data selection, analytical methods, and analysis plans.
- Draft and review statistical analysis plans (SAPs), analysis specifications, and study reports.
- Conduct primary data collection and secondary data use studies, including targeted literature reviews.
- Review analysis outputs and deliverables to ensure data accuracy and quality for publications or conferences.
- Collaborate with scientific stakeholders, study teams, and vendors to meet milestones and resolve operational issues.
Required Skills
- Graduate degree in Epidemiology.
- 7 to 10+ years of industry experience as an epidemiologist.
- Experience drafting and reviewing statistical analysis plans (SAPs).
- Proven ability to manage observational study lifecycles from feasibility to reporting.
- Experience conducting secondary data use studies and literature reviews.
- Ability to work with cross-functional stakeholders to manage study timelines.
Preferred Skills
- Experience in Oncology.
- Experience with Real World Evidence (RWE) and Real World Data (RWD) in a safety context.