Principal Research Specialist, Clinical Insights

job summary :

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responsibilities :

Come join the company’s Urology Clinical Sciences organization where we partner together to advance Urology for patients.

We are looking for a Principal Research Specialist to join our Urology Clinical Insights team. This role supports key commercialized products by developing and executing clinical research activities from real-world data sources and driving long-term evidence strategies.

This role creates and maintains all documentation pertaining to clinical research activities, designs studies utilizing these non-clinical trial data sources, builds cohorts through data element identification and mapping, and collaborates cross-functionally to ensure cohesiveness and appropriateness of research scope.

• 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 company 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 co-variates 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.

Quality System Responsibilities :

• 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 that supervise others, the following statements are applicable : Assures that appropriate resources (personnel, tools, etc.

are maintained in order to assure Quality System compliance and adherence to the company Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System.

qualifications : Required

Required

• 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, other software for exploring, structuring, and analyzing data sets
• Relational data modeling and querying expertise (SQL)
• Ability to work in a team environment and possess clear, concise communication skills written and verbal
• Excellent problem solving and analytical skills

Preferred

• 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

skills :

Clinical research, R Language, Clinical Study Design