Associate Manager, Clinical Data Sciences

Grow Your Career at Stryker as an Associate Manager Clinical Data Science!

As an Associate Manager for Clinical Data Sciences you will lead a diverse team of experts and collaborate with internal and external stakeholders to implement and execute Clinical Data Sciences initiatives for the Instruments division. This role involves driving operational planning building technical infrastructure to support excellence in evidence communication and integrating real-world data sources into Strykers clinical evidence strategy. You will provide leadership and mentorship to clinical expert staff fostering development and ensuring high-quality deliverables that advance clinical intelligence across the organization.

What you will do

• Establish the Clinical Data Sciences function at Instruments. Develop a strategy to grow the team and expertise to support business growth objectives.
• Lead and manage the Clinical Data Sciences team which will leverage data from various sources to foster clinical evidence communication to regulators global health funding authorities payers and customers and enable regulatory approvals/clearance market access and sustained product availability across the product lifecycle.
• Drive operational excellence by developing and maintaining technical infrastructure platforms and automation solutions to support effective evidence communication and efficiency.
• Drive innovation through data analytics predictive modeling and AI applications.
• Provide strategic insight into evidence requirements for global launch strategies identify gaps and define goals for Clinical Data Sciences initiatives in collaboration with Clinical Research Medical Affairs Regulatory Reimbursement & Market Access Marketing and R&D teams.
• Build and maintain clinical databases and data management systems to ensure effective and efficient availability of evidence for regulatory market access and marketing needs. Learn and leverage advanced analytics techniques including machine learning and artificial intelligence to interpret complex clinical datasets and uncover actionable insights.
• Oversee and manage planning communication and execution of Clinical Data Sciences initiatives across multiple simultaneous complex projects.
• Establish a process aligned with FDA and notified body guidance for using real world data (RWD) as part of the clinical strategy in global regulatory submissions. Ensure the approach includes a relevance and reliability assessment considers data quality and integrity and considers the strengths and limitations of using RWD to address a specific regulatory purpose (e.g. 510(k) submission pre-sub CER PMCF).
• Oversee and translate complex data into actionable insights for stakeholders.
• Define KPIs and performance objectives recruit and onboard top talent develop team capabilities and maintain high engagement while addressing performance issues proactively.
• Identify and oversee the qualification/approval of vendors.
• Support continuous improvement activities and participate in cross-divisional initiatives to advance Clinical Data Sciences and operational excellence.

What you need

• PhD or masters 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 (relevant research experience may also be considered).
• Experience conducting clinical evaluations is strongly preferred.
• Deep understanding of global regulatory clinical evidence requirements (clinical investigation evaluation post-market follow-up) and ability to apply ISO FDA and international standards.
• Strong quantitative analysis skills and project management expertise; ability to prioritize and manage multiple complex projects.
• Demonstrated ability to lead and collaborate with cross-functional teams influence across the organization and communicate effectively (written verbal interpersonal).
• High integrity professionalism and ability to maintain confidentiality; strong organizational skills and adaptability.

Preferred Qualifications

• 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.