Job Description

The primary function of the Senior Statistician is to provide expertise in statistical analysis and data science with secondary functions of applying Machine Learning (ML) and artificial intelligence (AI). They will collaborate with cross-functional teams to design experiments, analyze data using advanced statistical and computational techniques, and provide recommendations based on statistical findings. The Senior Statistician will also train and mentor junior Statisticians to ensure the consistent application of statistical techniques and, where applicable, foster the adoption of AI and ML methodologies.

• Mentor and develop statisticians and engineers for the proper application of advanced statistical techniques across all Cook Medical entities, fostering growth and professional development in a collaborative and supportive environment.
• Collaborate closely with cross-functional teams to design innovative experiments and develop statistical models for data analysis, contributing to impactful discoveries and advancements.
• Provide support to various production, engineering, quality, and technical teams, leveraging your statistical expertise to evaluate data and drive effective problem-solving initiatives.
• Develop comprehensive and engaging training materials for Statisticians, Interns, and Engineering/Quality Engineering, playing a vital role in enhancing the skills and knowledge of the team members.
• Assume the responsibility of an independent statistical reviewer, reviewing and approving protocols and reports in accordance with Cook Medical Quality Management Systems, ensuring the highest level of statistical integrity.
• Ensure the adequacy of sampling methods for their intended use, contributing to accurate and reliable data analysis.
• Effectively communicate complex statistical methods and results to non-statisticians, fostering a shared understanding and promoting the proper utilization of statistical techniques.
• Develop and apply complex statistical techniques as needed and demonstrate the statistical validity of these techniques.
• Deliver engaging and informative presentations and documentation on complex subject material, effectively conveying important concepts and findings.
• May apply AI and ML algorithms to complex datasets to uncover patterns, trends, and insights that drive business decisions and optimize processes.
• Collaborate with global Cook Medical entities to harmonize statistical methodologies, AI/ML practices, and promote standardization across the organization.
• Create, maintain, and improve data workstreams, as appropriate, with data engineers.
• Revise and update policies and procedures related to statistical techniques, AI, ML, and data science methodologies, ensuring compliance with regulatory requirements and global quality management systems.
• Stay up-to-date with the latest statistical techniques, AI advancements, and industry best practices in data science.
• Critical thinking and attention to detail required.
• May interface with internal, 3rd party audits e.g. FDA, Notified Body, etc.
• Keep a calm and receptive demeanor in fast-paced situations, effectively managing and responding to challenges with composure and professionalism.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
• Ability to remain calm and receptive in fast paced situations.

• Masters or above in Statistics, Biostatistics, Data Science, or a related field.
• Minimum of 3 years applied experience including direct responsibility with application of statistical techniques within clinical, development, and/or manufacturing role required.
• Demonstrated ability to manage multiple complex statistical projects.
• Preferred experience in applying artificial intelligence, machine learning, and data science in the medical device or healthcare industry.
• Demonstrated knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971).
• Working knowledge of software tools such as Minitab, R, JMP, Python preferred.
• Experience with Minitab preferred.
• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) preferred.

Physical Requirements:

• Works under general office environmental conditions.
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Some travel involved.
• Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.

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