Lead Statistician

Cook Medical is seeking a highly skilled and experienced Lead Statistician with deep expertise in experimental design and non-clinical testing to support our Quality Assurance and Quality Engineering teams. This pivotal role focuses on leading statistical innovation and data-driven decision making across the organization, mentoring personnel in advanced statistical techniques, and ensuring robust application of statistical science throughout the product lifecycle. The Lead Statistician will serve as the primary subject matter expert for experimental methodology, statistical consulting, and predictive modeling, while contributing to regulatory audits and inquiries. This position requires a leader who can translate complex statistical analysis into actionable insights, drive process improvement initiatives, and collaborate across global teams to uphold Cook Medical's commitment to quality excellence and regulatory compliance. The ideal candidate will champion best practices in experimentation and foster a culture of statistical rigor in our medical device development and manufacturing environments. 

• Lead advancements in non-clinical experimentation across Cook Medical entities. 

• Mentor and develop statisticians, engineers, and quality professionals in advanced statistical techniques.   

• Serve as a subject matter expert on statistical applications throughout the product lifecycle, supporting audits and regulatory inquiries.   

• Collaborate with technical teams to design studies and develop statistical analysis plans.   

• Support production, engineering, quality, and technical teams in data evaluation and problem-solving.   

• Manage multiple complex statistical projects and oversee junior statisticians’ work.   

• Develop and deliver training materials on statistical techniques for statisticians, interns, engineers, and quality professionals.   

• Review and approve protocols and reports in compliance with Cook’s Quality Management System.   

• Ensure sampling methods and statistical techniques are appropriate and valid.   

• Communicate complex statistical concepts clearly to non-statisticians and executive management.   

• Maintain and improve data workflows in collaboration with data engineers.   

• Interface with internal and third-party audits, including FDA and Notified Bodies.   

• Adhere to regulatory requirements (FDA 21 CFR 820, ISO 13485, ISO 14971).   

• Promote continuous professional development and maintain all required training.   

• Uphold safety standards, company policies, and confidentiality agreements.   

Required Qualifications:   

• Master's degree or higher in Statistics, Biostatistics, Engineering, or related scientific discipline with emphasis on experimental design and statistical methods 

• Minimum of 5 years of applied experience in Design of Experiments (DOE), factorial design, response surface methodology, and advanced statistical techniques within clinical, development, or manufacturing roles 

• Proven ability to manage multiple complex statistical projects including process optimization, reliability testing, and method validation 

• Strong knowledge of medical device regulations (ISO 13485, 21 CFR 820) and risk management (ISO 14971) with experience in statistical sampling plans and process validation 

• Proficiency in statistical software including Minitab, R programming, JMP, with experience in statistical modeling and data visualization 

• Demonstrated experience with ANOVA/MANOVA, regression analysis, Statistical Process Control (SPC), and Measurement System Analysis (MSA) 

• Effective communication skills with ability to deliver statistical training and work independently and collaboratively 

• Ability to work under general office conditions, with some travel as needed 

Preferred Qualifications:   

• Advanced expertise in Minitab statistical software. 

• Experience with Python (for statistics), SAS, or Design Expert software 

• Proficiency in Microsoft Office suite with advanced Excel skills. 

• Prior experience mentoring and developing junior staff in experimental design methodology and statistical best practices 

• Background in Six Sigma/DMAIC, Quality by Design (QbD), or robust parameter design 

• Experience with Taguchi methods, screening experiments, and optimization experiments 

• Knowledge of ASTM standards and medical device testing protocols 

• Publications or presentations on experimental design or applied statistics in regulated industries 

 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