At **Parexel** , we believe in the power of real-world data to transform clinical research and improve patient outcomes. We are seeking a passionate and experienced **RWE** Specialist join our team and support the design and execution of clinical trials through advanced analytics and evidence generation.
Our team is expanding its needs in Real-World Data (RWD). This position will support both exploratory work and trial support (with preference for candidates experienced in both).
The primary focus on oncology and hematology areas, but not exclusively.
**Title:** RWE Specialist
**Location:** Remote - US
**The ideal candidate demonstrates proficiency in the following areas:**
+ Strong programming capabilities, data mining, automation.
+ Works with a sense of urgency and handle frequent information requests that might not be fully specified.
+ Curate and assess the quality of real-world data (RWD) assets to ensure their suitability and understanding for intended use.
+ Design and implement data pipelines to transform raw RWD into datasets ready for analysis.
+ Collaborate with cross-functional teams-including Biostatistics, Data Science, HEOR, Epidemiology/Safety, Clinical, and IT-to define data requirements and analytical strategies.
+ Conduct exploratory data analyses, identify patient cohorts, and perform data summary analytics to support real-world evidence (RWE) generation.
+ Participate in the design of RWE studies, including the development of methodologies, data analysis, interpretation, and reporting of study results.
+ Author or review study documents such as protocols, statistical analysis plans, study reports, publications, and study-level specifications.
+ Develop and maintain documentation detailing data sources, transformations, and analytical methods.
+ Ensure all work complies with data governance, privacy, and regulatory standards.
+ Stay up to date with industry and regulatory trends, tools, and best practices in RWD/RWE analytics.
+ Continually expand technical knowledge of statistical considerations in real-world evidence generation to ensure high-quality study design and analysis.
+ Enhance understanding of the drug development process, as well as regulatory and commercial requirements.
**Responsibilities**
+ Focus on exploratory work to generate evidence supporting clinical trial design, including outcome summaries and insights
+ Work with licensed databases (e.g. TriNetX, Flatiron, Optum and several other vendor-licensed databases)
+ Address requests from clinical teams and statisticians: serve as the main point of contact for data requests, working independently
+ Interpret underlying questions, that are not fully defined initially (e.g. patient criteria, and restrictions)
+ Understanding requirements from team and translating those into concept sheet documents/RWD exploration plans (written documents)
+ Establish and manage general timelines
+ Demonstrate strong data mining skills to extract relevant information from US and ex-US databases
+ Pull and analyze data independently
+ Handle data that can be "quite messy" - ability to quickly navigate datasets to find information and provide quick and accurate evidence
+ Innovative component: create tools to expedite manual steps, automate processes, replace manual steps, and increase speed
**Qualifications & Experience**
+ Master's or PhD in Epidemiology, Biostatistics, Data Science, Health Informatics, or a related field.
+ 3+ years of experience working with real-world healthcare data (claims, EMR, registries, etc.).
+ 2+ years of experience in pharmaceutical industry (e.g. Pharma, CRO, Biotech) and clinical trials.
+ Proficiency in SAS, R, Python, or similar tools for data manipulation and analysis. AI/ML knowledge is a plus.
+ Good understanding of industry RWD vendor database.
+ Experience with RWD data curation, engineering, exploration, and quality control in large-scale datasets.
+ RWD trial design and analysis experience
+ Ability to communicate complex real-world data concepts to non-technical stakeholders.
+ Ability to work successfully within cross-functional teams
+ Ability to organize multiple work assignments and establish priorities
+ Strong understanding of healthcare industry regulatory compliant data standards.
+ Good understanding of regulatory requirements & clinical trial design is preferred.
**Why Parexel?**
At Parexel, we put patients first. Our global team is united by a shared commitment to scientific excellence, operational integrity, and continuous learning. We foster a culture of inclusion, flexibility, and purpose-driven work-where your contributions directly impact the future of healthcare.
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.