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STStryker Leibinger GmbH & Co. KG

Associate Manager, Clinical Data Sciences(m/w/x)

Freiburg im Breisgau
Vollzeitmit HomeofficeSenior
AI/ML
Data Science

Establishing Clinical Data Sciences function at a medical technology specialist for resorbable implants, driving evidence communication. 6+ years in medical device field with deep regulatory understanding (ISO, FDA) required. Building and leading a new Clinical Data Sciences function.

Anforderungen

  • PhD or master’s degree in life sciences, biomedical engineering, epidemiology, health services research, biostatistics, data science, or related field
  • Minimum of 6 years of experience in the medical device field
  • Experience conducting clinical evaluations
  • Deep understanding of global regulatory clinical evidence requirements and ability to apply ISO, FDA, and international standards
  • Strong quantitative analysis skills and project management expertise
  • Demonstrated ability to lead and collaborate with cross-functional teams
  • High integrity, professionalism, and ability to maintain confidentiality
  • Experience with healthcare real-world data sources and authoring study protocols, reports, abstracts, and publications
  • Knowledge of standard statistical software (e.g., SAS, R, Stata)
  • Experience with recruiting, people development, and process improvement
  • Demonstrated leadership skills and experience with trending and analysis reporting

Aufgaben

  • Establish the Clinical Data Sciences function at Instruments
  • Develop a strategy to grow the team and expertise
  • Lead and manage the Clinical Data Sciences team
  • Leverage data to foster clinical evidence communication
  • Drive operational excellence through technical infrastructure
  • Develop automation solutions for effective evidence communication
  • Drive innovation using data analytics and predictive modeling
  • Provide strategic insight into evidence requirements for global launches
  • Identify gaps and define goals for Clinical Data Sciences initiatives
  • Build and maintain clinical databases and data management systems
  • Utilize advanced analytics techniques to interpret clinical datasets
  • Oversee planning and execution of Clinical Data Sciences initiatives
  • Establish processes for using real-world data in clinical strategy
  • Ensure relevance and reliability assessments for regulatory submissions
  • Translate complex data into actionable insights for stakeholders
  • Define KPIs and performance objectives for the team
  • Recruit and onboard top talent while developing team capabilities
  • Identify and oversee vendor qualification and approval
  • Support continuous improvement activities across divisions

Berufserfahrung

  • 6 Jahre

Ausbildung

  • Master-Abschluss

Sprachen

  • Englischverhandlungssicher

Tools & Technologien

  • SAS
  • R
  • Stata
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