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Principal Clinical Insights Research Specialist
1 month ago
Responsibilities:
- Support strategic growth of our team's Real-World Evidence (RWE) capabilities and demonstrate ROI in the use of these new clinical data sources.
- Plan and execute feasibility and analysis of Urology RWE studies programmatically utilizing data science techniques and contribute to post-market documentation, publications, and other documents as needed.
- Design studies utilizing administrative claims, Electronic Health Records (EHR), and other RWE data sources by applying clinical research methodologies (e.g., research question development, population inclusion/exclusion, reduction of bias, etc.).
- Develop coding definitions utilizing reimbursement code sets (ICD-10-CM, ICD-10-PCS, CPT, etc.) and medical terminologies (SNOMED, LOINC, RxNorm, etc.) for populations, outcomes, and covariates of interest in the Urology space.
- Collaborate cross-functionally with Clinical Strategy, Sci Comm, Biostatistics, Medical Safety, Legal, and Compliance to design and run RWE studies.
- Manage internal and external project materials and timelines.
- Participate as a key team member on process development and improvement efforts to meet Urology VIP goals.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- For those individuals who supervise others, the following statements are applicable.
- ssures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
- Bachelor's Degree in a related field and 9+ years of related work experience (including data analytics, data management, health economics, medical affairs, clinical risk, clinical trial operations, clinical safety, quality assurance or regulatory affairs) or advanced degree (PhD, research-based MS, MD, RN/DVM) in a related field with 7+ years of related work experience.
- Expertise in leveraging medical coding systems and terminologies for research applications (ICD-9/10, CPT, SNOMED, LOINC, RxNorm, etc.).
- Significant experience using Python, R, and other software for exploring, structuring, and analyzing data sets.
- Relational data modeling and querying expertise (SQL).
- bility to work in a team environment and possess clear, concise communication skills - written and verbal.
- Excellent problem-solving and analytical skills.
- Medical device or Clinical experience relating to Urology.
- Experience in retrospective research design with real-world data including Claims data inclusive of Charge Master Data and/or Electronic Health Record (EHR) data.
- Scientific writing experience.
- Physician-facing experience.
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