Hybrid Medical Device Statistician

Akkodis; Bloomington (IN); Hybrid; USD 69,000 - 98,000; Full time

Benefits offered by this job

Medical insurance

401K plan

Paid time off

Job summary

Akkodis is seeking a Hybrid Medical Device Statistician for a 12-month contract in Bloomington, IN, with potential extension through 2028 or conversion after 12 months. You will support statistical techniques across the device lifecycle, update policies, and ensure quality system compliance.

Qualifications include an MS in Statistics or related field with 5–8 years in medical device or related industries, experience with DOE, statistical modeling, and proficiency in Minitab and Office tools.

Qualifications

• MS in Statistics or related field preferred; work experience considered in lieu of degree
• DOE (Design of Experiment) and statistical modeling experience required
• Familiarity with medical device regulations (ISO 13485, 21CFR) and risk management (ISO 14971)
• Experience applying statistics in development and manufacturing contexts

Responsibilities

• Develop and execute statistical analyses; support production, engineering, and quality teams
• Review protocols and reports per quality system requirements (independent statistical reviewer)
• Ensure sampling methods are appropriate for intended use
• Communicate statistical concepts to non-statisticians clearly
• Present and document complex statistical methods and results

Skills

Statistical methods

DOE design of experiments

Analytical thinking

Communication skills

Education

MS in Statistics

Bachelor in related field

Tools

Minitab

Microsoft Office

Job description

Akkodis is seeking a Hybrid Medical Device Statistician for a 12-month contract job, with possible extension yearly through 2028, or conversion after 12 months, with a client in Bloomington, IN. You will support functional areas in proper implementation and execution of statistical techniques used throughout the lifecycle of a medical device. You will revise 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.

Rate Range: $60.71/hour to $60.71/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Remote Medical Device Statistician job responsibilities include:

• 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

• May interface with internal, 3rd party audits e.g. FDA, Notified Body, etc)

• Manage conflict resolution as it relates to technical situations

• Must work and interact effectively and professionally with and for others throughout various levels of the global organization

• Must maintain company quality and quantity standards

• Ability to work in collaborative and independent work situations and environments with minimal supervision

Desired Qualifications:

• M.S. in Statistics or above preferred, Bachelors or above in related scientific discipline may be considered with appropriate working experience. Five to eight years of experience required - preferred medical device, but automotive and pharmaceutical would also be sufficient.

• Previous experience must include direct responsibility with application of statistical techniques within development and manufacturing role. Must have DOE (Design of Experiment)and statistical modeling experience (diagnostic modeling, distribution fitting, bias detection, translating highlights to engineers)

• 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.

• Must have effective oral, written and presentation communication skills

• Must have excellent analytical and problem-solving skills

• Critical thinking and attention to detail required

• Ability to remain calm and receptive in fast paced situations

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers