Requisition ID 2021-8588 Job Location(s) Bloomington IN United States Travel None Position Type Full Time Company Cook Inc. Category Quality
Overview
The Statistician at Cook Incorporated supports functional areas in proper implementation and execution of statistical techniques used throughout the lifecycle of a medical device. The Statistician Specialist revises policies and procedures on statistical techniques including Hypothesis Testing, Confidence Limits, Sample Size Determination, Design of Experiment, Process Capability, Measurement System Analysis, Acceptance Sampling, Statistical Process Control, etc.
Responsibilities
Develop required training and participate in execution of training
Support various production, engineering, quality, and technical teams in the evaluation of data and problem-solving
Assist with design and execution of statistical analysis
Approve protocols and reports as required by the quality system (i.e. independent statistical reviewer)
Ensure that sampling methods are adequate for their intended use
Communicate with non-statisticians on proper use of statistical methods and interpretation of results
Develop and apply complex statistical techniques as needed and demonstrate the statistical validity of these techniques
Effectively present and document complex subject material
Critical thinking and attention to detail required
May interface with internal, 3rd party audits e.g. FDA, Notified Body, etc.
Manage conflict resolution as it relates to technical situations
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
Qualifications
Bachelors or above in related scientific discipline may be considered or experience of such kind and amount as to provide a comparable background
M.S. in Statistics or above preferred
Previous experience including direct responsibility with application of statistical techniques within clinical, development, and/or manufacturing role, preferred
Demonstrated knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
Working knowledge of statistical software, 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
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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.