Industry: Biopharmaceutical 

Job Description:

• Perform feasibility analysis for studies. 
• Conduct literature review   
• Plan observational studies and draft protocol synopsis (or protocol concept sheet) 
• Determine observational study design criteria – including source data, analytical methods and analysis plans  
• Draft and review observational study protocols  
• Draft and review observational study analysis specifications, including statistical analysis plans (SAPs) Draft and review observational study reports  
• Conduct observational studies, both primary data collection and secondary data use studies  
• Conduct study data analysis according to observational methods  
• Conduct data analysis according to observational methods  
• Review analysis outputs for quality, including study analysis, ad hoc analysis, analysis to support conference or publications   
• Conduct quality review of all deliverables to ensure data and results are accurate  
• Work with scientific and operational stakeholders to identify and resolve issues  
• Collaborate with study teams, vendors and other stakeholders to advance study and analysis deliverables  
• Work with relevant stakeholders to meet study milestones and timelines  
• Participate in program or study planning meetings  
• Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks 
• Contribute to ongoing improvement of programming processes and methodology  
• Perform other related duties as required by the Department. 

Experience: 

• Graduate degree in Epidemiology with 7 – 10+ years industry experience as an epidemiologist. 
• Oncology RWD/RWE Study Experience preferred