Clinical Epidemiology and Real World Evidence Project Manager

2 weeks ago

Bengaluru, Karnataka, India Stryker Global Technology Center Pvt Ltd. Full time

Job Summary:

This position leads the design and execution of regulatory-grade RWE studies to support clinical evidence needs. Working with key stakeholders, the role will execute on key RWE deliverables, establish standards and best practices for RWE study design and reporting, and support the integration of real-world data sources as an essential part of the clinical evidence generation strategy for Stryker's product portfolio.

Responsibilities:

  • Lead design and execution of RWE studies in close collaboration with internal stakeholders from Clinical Strategy, Medical Affairs, and Clinical Data Science.
  • Author and/or oversee development of study protocols, reports, and peer-reviewed publications using RWD and collaborate cross-functionally to integrate RWD into global publication strategies.
  • Ensure scientific rigor and serve as a methodology expert for real-world evidence generation; select and implement appropriate analytic methods aligned to research needs.
  • Collaborate closely with data management and biostatistics functions to ensure data quality and deliver robust data analyses utilizing scientifically valid and accepted methodology for RWD.
  • Conduct feasibility assessment of relevant data sources for specific devices and indications to ensure data is fit-for-purpose.
  • Collaborate with academic institutions, health systems, registries and/or other health data partners to identify additional real-world data sources for medical device evidence generation.
  • Ensure quality and performance standards for RWE projects are realistic and attained, and studies are conducted in line with quality/compliance framework.
  • Identifies areas of improvement with RWE processes and procedures, develops and implements best practices, and works to improve efficiencies and effectiveness.
  • Participate in cross-functional and cross-divisional initiatives regarding RWE.

Requirements:

  • Advanced degree (MSc, MPH, PhD) in epidemiology, health services research, health outcomes research, biostatistics, data science, or related field.
  • 3+ years relevant experience in epidemiology and/or observational research in academia, a contract research organization, and/or the medical device or pharmaceutical industry.
  • Hands-on experience with real-world data (RWD) sets such as patient registries, electronic medical records, hospital billing data, and insurance claims databases.
  • A sophisticated understanding and ability to analyze and interpret quantitative data is required together with working knowledge of RWE/observational study design and methodology.
  • Knowledge of standard statistical software (e.g., SAS, R, Stata) and/or demonstrated ability to collaborate closely with statistical programmers.
  • Excellent oral and written communication skills, experience authoring study protocols, study reports, and peer-reviewed publications using RWD preferred.
  • Well-developed interpersonal skills and the ability to work well independently as well as with colleagues and customers.
  • Strong organizational skills, with ability to effectively and efficiently handle multiple tasks simultaneously, with precision, and to adapt to changes in responsibilities and workloads.
  • Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic.
  • Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA and GDPR guidelines, and other confidential information.

Travel Percentage: 10%

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