Epidemiologist, Real-World Evidence, PhD (Remote US)

Epidemiologist, Real-World Evidence (PhD) - International Consulting Associates, Inc. (Remote) About ICA, Inc. International Consulting Associates, Inc. is a rapidly growing company, located in the D.C./Metro area. We were founded in 2009 to assist government clients with evaluating and achieving their objectives. We have become a trusted advisor helping our clients by offering cutting-edge innovation and solutions to complex projects. Our small company has grown significantly, and we're overjoyed at the opportunity to expand yet again! We are results-focused and have a proven track record supporting federal agencies and large government services primes in three main areas: Research and Data Analysis, Advanced-Data Science, and Strategic Services. We currently support multiple analytics and research programs across HHS. At ICA, we believe our success starts with our people. We foster a collaborative "one team" environment where work-life balance isn't just talked about – it's prioritized. We're building dynamic, highly skilled teams in a welcoming and supportive atmosphere. If you're passionate about using your technical expertise to make a difference, we want to talk to you. We are looking for an Epidemiologist to join our growing team! Role ICA’s Health Technology Assessment (HTA) team supports federal clients in their mission to protect and promote public health by conducting Systematic Reviews (SRs) in a wide variety of clinical content areas. Joining the HTA team is an opportunity to help inform decisions related to pharmacological and medical devices and thus improve the lives and well-being of millions of people. We are seeking a highly skilled epidemiologist with solid expertise in healthcare data and real-world evidence (RWE) generation, including hands-on experience working with different types and sources of RWD (especially electronic health record (EHR) and administrative claims data). The RWE Epidemiologist’s primary responsibility will be to lead collaborations with clients and stakeholders in the use and evaluation of real-world data sources used to support evidence assessment for medical devices. Successful candidates will have a strong background in RWD analytics and the use of RWE in regulatory decision-making and must hold a PhD in Epidemiology or Health Informatics. Prior experience working in a fast-paced consulting environment is preferred.

Responsibilities

The RWE Epidemiologist will be responsible for conducting assessments of diverse RWD sources and advancing RWE initiatives for high-priority medical device safety and surveillance topics. In this role, the RWE Epidemiologist will rely on deep understanding of RWD architecture, curation, and analysis methodologies across different types of health data to support scientifically robust and actionable research that aligns with regulatory expectations. This position requires strong collaborative skills to work closely with government clients and RWD stakeholders, with the ability to independently deliver detailed assessments of key research, pre-market, and regulatory materials relevant to RWE generation for medical devices.

• Conduct assessments of varying scope on the relevance, reliability, quality, and feasibility of RWD sources to support RWE generation for regulatory decision-making
• Identify and evaluate data curation, architecture, and bias considerations for RWE conducted across multiple healthcare data types
• Ensure understanding of client needs for a variety of client requests
• Conduct reviews of peer-reviewed research and regulatory materials to evaluate feasibility for future RWD studies
• Collaborate with epidemiologists, data scientists, and non-technical stakeholders on RWE initiatives

Qualifications/Minimum Requirements

• Minimum 5 years' hands-on experience conducting data curation activities and analysis of RWD data, including EHR and administrative claims data, with direct experience executing protocols
• Doctorate Degree in Epidemiology (required)
• Mastery of key considerations, principles, and best practices for RWE generation
• Deep understanding of regulatory guidance and decision-making related to use of RWE –
• Ability to identify potential biases affecting RWD quality and reliability
• Prior experience conducting RWD studies as project/methodological lead
• Strong analytical, critical thinking and communication skills including technical writing and editing
• Excellent writing skills/ability to summarize complex information in narrative form
• Ability to work well alone or in small groups, as dictated by the project’s needs
• Ability to meet client deadlines for deliverables
• Ability to shift priorities while contributing to or leading multiple projects
• Prior experience in working with external stakeholders
• Demonstrated qualitative and analytical skills with a strong understanding of data management, statistical, and research methodologies -Knowledge or expertise with pharmaceutical and heal

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