Description

In this role, you will lead a dynamic team in Clinical Data Sciences, driving innovation and operational excellence while collaborating with various stakeholders to enhance clinical evidence communication and support regulatory approvals.

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

Tools & Technologies