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.