Senior Real World Data Scientist

United States, California, Santa Clara

Position Summary:

 
The Senior Real World Data (RWD) Scientist collaborates with colleagues from other Diagnostics functions and teams to identify opportunities where real-world data can support diagnostics product development, commercialization and market access. The Senior RWD Scientist has the primary strategic and operational responsibilities for the design, conduct, analysis and reporting of RWD studies using a variety of observational healthcare databases. This Senior RWD Scientists partners with Data Analysts to define and clarify analysis methods, oversees the execution of analyses, and guides results interpretation to ensure data quality standards. The Senior RWD Scientist is typically the lead representative on cross-functional real-world data analysis teams. The RWD Scientist also manages and incorporates feedback from medical and scientific affairs, and biomarker discovery teams in creating, confirming and validating disease hypotheses for real-world data projects. This position is primarily focused on oncology real-world data.
 
Responsibilities Include:
  • RWD studies: Develops RWD study protocols and analysis plans. Collaborates with external partners (e.g., key opinion leaders, academic institutions, CROs) on design and implementation of RWD studies. Develops analysis specifications in partnership with RWD Data Analysts. Authors or contributes to study reports, publications, and presentations.
  • Forms strong partnerships with life cycle teams, medical & scientific affairs colleagues, market access groups and other teams to understand RWD analysis needs and priorities, and develops RWD strategies based on these needs.
  • Contributes evidence and expertise to Regulatory submissions, Health Technology Assessments, Market Access & Reimbursement dossiers in collaboration with global and local cross-functional teams.
  • Contributes to advancing learning and understanding of RWD within the Diagnostics Division. Maintains knowledge of RWD science methods and their application.
  • Maintains knowledge of RWD sources applicable to Diagnostics product portfolio.
  • This role requires business travel (both domestic and international) of up to 20%.
Skills:
  • Detailed understanding of public and private real-world data sources, including national and regional disease data registries.
  • Detailed understanding of biomedical ontologies and controlled vocabularies in the context of healthcare data analysis.
  • Very good knowledge and extensive experience in design, implementation and reporting of real-world data studies in the diagnostics/pharmaceuticals industry.
  • Good ability to explain strengths and limitations of real-world datasets – such as national/regional registries, EMRs and other clinical data sources- in context of designing real-world data study designs.
  • Good knowledge of regulatory guidelines for diagnostics/pharma, and understanding of reimbursement mechanisms for in vitro diagnostic tests.
  • Excellent communication and collaborations skills (including interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners) .
  • Excellent project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors, and external vendors).
  • Very good strategic ability (including problem-solving and critical thinking skills, ability to drive drug development and patient access strategies, agility that extends beyond RWD expertise).
  • Good mentoring skills to support associate RWD Scientists and Analysts.