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Sr. Statistician

Hybrid for a 12-month contract opportunity- with the possibility of yearly extension through 2028 or conversion after 12 months

Bloomington, IN

Contract on W2

This role offers the opportunity to provide high-impact statistical leadership across the full lifecycle of medical device development and manufacturing. The Sr. Statistician will join a small but talented statistical consulting team and partner with engineering, quality, production, and technical teams to ensure appropriate application of statistical methods, strengthen data-driven decision-making, and support compliance with medical device quality system and regulatory expectations.
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.

Sr. Statistician Hybrid job responsibilities include:

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

Five to eight 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

Why this role is exciting:

This is an opportunity to serve as a key statistical partner within a highly regulated medical device environment, where sound statistical thinking directly supports product quality, patient safety, manufacturing robustness, and continuous improvement. The Sr. Statistician will have the opportunity to influence statistical practice across multiple functional areas, partner with diverse technical teams, and help strengthen the organization's data-driven culture.

Ayush Sharma Sr. US Technical Recruiter

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