Stryker Leibinger GmbH & Co. KG
Associate Quality Manager(m/w/x)
Full-timeWith HomeofficeSenior
Freiburg im Breisgau
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STStryker Leibinger GmbH & Co. KG
Associate Manager, Clinical Data Sciences(m/w/x)
Freiburg im Breisgau
Full-timeWith Home OfficeSenior
AI/ML
Data Science
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- Stata
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker Leibinger GmbH & Co. KG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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STStryker Leibinger GmbH & Co. KG
Associate Manager, Clinical Data Sciences(m/w/x)
Freiburg im Breisgau
Full-timeWith Home OfficeSenior
AI/ML
Data Science
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAS
- R
- Stata
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker Leibinger GmbH & Co. KG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Stryker Leibinger GmbH & Co. KG
Industry
Healthcare
Description
Das Unternehmen ist auf die Herstellung von resorbierbaren Implantaten in der Medizintechnik spezialisiert.
Not a perfect match?
- Stryker Leibinger GmbH & Co. KG
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Senior Product Transfer Quality Engineer(m/w/x)
Full-timeWith HomeofficeSeniorFreiburg im Breisgau - Bristol Myers Squibb
Senior Medical Science Liaison, Cardiovascular(m/w/x)
Full-timeWith HomeofficeSeniorMainz, Freiburg im Breisgau, Ulm, Heilbronn - Intuitive
Manager NPI/Project Procurement(m/w/x)
Full-timeWith HomeofficeSeniorFreiburg im Breisgau