Job Description:
• We are looking for an experienced professional to support real-world evidence (RWE) initiatives. The role requires a doctoral degree in Epidemiology or a closely related field, with a minimum of three years of hands-on experience in observational research.
• Responsibilities will include preparing study concepts, maintaining tracking tools, and acting as a representative for RWE in cross-functional groups.
• Candidates should be proficient in communicating complex findings clearly and may find an advantage in familiarity with SAS or R.
Responsibilities:
• Design and execute observational studies using healthcare databases such as claims, EHR, registries, and other secondary data sources.
• Develop study protocols, statistical analysis plans (SAPs), and technical documentation for RWE projects.
• Conduct data analysis, interpretation, and quality review to ensure scientific accuracy and compliance with study objectives.
• Collaborate with biostatistics, clinical, medical affairs, regulatory, and commercial teams to support evidence-generation strategies.
• Support publication activities, including abstracts, manuscripts, posters, and conference presentations.
• Evaluate data sources and study feasibility for research questions related to safety, effectiveness, and health outcomes.
• Ensure adherence to regulatory and industry guidelines, including pharmacoepidemiology best practices and data privacy requirements.
• Present study findings and recommendations to internal stakeholders and external partners in a clear, concise manner.
• Monitor advancements in real-world data (RWD), epidemiologic methods, and healthcare analytics to improve research quality.
• Assist in vendor management and coordination with external research partners/CROs for study execution and deliverables.
Remote
Skills:
Best Practices, Biostatistics, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Data Analysis, Epidemiology, Feasibility Analysis, Healthcare, Maintain Compliance, Medical Affairs, Medical Record System, Pharmacoepidemiology, Publications, Quality Management, R Programming Language, Regulations, Regulatory Compliance, Research Protocols, Safety/Work Safety, Statistics, Technical Writing, Vendor/Supplier Management
About the Company:
Katalyst Healthcares & Life Sciences