Senior Statistician

Job Description:

The successful candidate will support the implementation, execution, and improvement of statistical techniques used throughout the organization, including hypothesis testing, confidence intervals, sample size determination, experimental design, process capability assessment, measurement system analysis, acceptance sampling, statistical process control, general statistical modeling, and related methods. This role may also contribute to the revision of policies, procedures, and training materials related to statistical practice

Key Responsibilities:

• Provide statistical support and guidance to production, engineering, quality, and technical teams in the evaluation of data, investigation of issues, and development of practical solutions
• Design, review, and execute statistical analyses to support product development, process validation, manufacturing improvements, quality investigations, and ongoing process monitoring
• Serve as an independent statistical reviewer for protocols, reports, and other quality system documentation as required
• Ensure sampling plans and statistical methods are appropriate, justified, and fit for their intended use
• Practice experimental design – collaborate with engineering teams during R&D to address and solve complex design problems, aid in planning and structuring experimental designs, perform thorough data analysis and model building, and enact response surface methodology to establish optimal manufacturing process settings and product design characteristics.
• Apply and explain statistical techniques such as hypothesis testing, confidence intervals, sample size determination, process capability, MSA, acceptance sampling, SPC, distribution fitting, diagnostic modeling, bias detection, and statistical modeling
• Develop, revise, and support training on statistical methods, procedures, and best practices
• Communicate statistical concepts clearly and effectively to engineers, quality professionals, production teams, and other non-statistical audiences
• Translate statistical findings into practical, actionable recommendations for technical and business stakeholders
• Develop and apply advanced or specialized statistical techniques as needed, while clearly documenting the rationale and statistical validity of the approach
• Present and document complex technical subject matter in a clear, concise, and defensible manner
• Support internal, third-party, FDA, and Notified Body audit activities as needed
• Help resolve technical disagreements by providing objective, data-driven statistical guidance
• Work effectively and professionally with individuals and teams across multiple levels of a global organization
• Maintain company quality and productivity standards
• Work successfully in both collaborative and independent environments with minimal supervision

Desired Qualifications:

• M.S. in Statistics or related quantitative discipline preferred; Bachelor’s degree in statistics, mathematics, engineering, data science, or related scientific discipline may be considered with appropriate experience
• 5-8 years of relevant experience required; medical device experience preferred, though pharmaceutical, automotive, or other regulated manufacturing experience may also be considered
• Direct experience applying statistical techniques in product development, manufacturing, quality, validation, or process improvement environments
• Strong experience with Design of Experiments, statistical modeling, diagnostic modeling, distribution fitting, bias detection, sample size justification, and translation of statistical results for engineering and quality audiences
• Demonstrated knowledge of medical device quality and regulatory expectations, including ISO 13485, 21 CFR requirements, and ISO 14971 risk management principles
• Working knowledge of statistical software required; Minitab experience preferred
• Proficiency with Microsoft Office products, including Word, Excel, PowerPoint, and Outlook
• Strong written, verbal, and presentation communication skills
• Excellent analytical, critical thinking, and problem-solving skills
• Strong attention to detail and ability to produce clear, accurate, audit-ready documentation
• Ability to remain calm, objective, and receptive in fast-paced or technically challenging situations