Job description

Statistician II (North Chicago, IL Area) | Competitive Pay!

SMS Staffing Inc is Hiring Immediately.

We are looking for a skilled Statistician II to start ASAP in the Lake County, IL area. Come join the SMS team! It takes more than top-notch facilities, modern equipment, and innovative technologies to become our customer’s most trusted supplier. It takes people who are committed to our customer’s success and who are willing to go the extra mile to get the job done right.

Job Title: Statistician II

Location: North Chicago, IL, US

Job Type: Contract, 9 months

Shift Structure:
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Monday to Friday

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8:00 AM to 5:00 PM

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40 hours per week

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Onsite (open to hybrid)

About the Client Company:
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A global healthcare leader, creating breakthrough science to improve people’s health. Our client is always looking towards the future, anticipating changes in medical science and technology.

Job Summary:
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Provide appropriate statistical input into study design and analysis of data. Ensures accuracy of programs and documents. Participates in statistical or process related presentations to customers. Responsible for implementing and maintaining the effectiveness of the quality system.

About the Role:
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Developing Statistical Plan: Effectively communicates with project manager/CRA to understand objectives of the study. Follows the appropriate operating procedure required for developing the statistical plan. Demonstrates the ability to research and provide appropriate statistical input to the study design. Using templates or examples, writes accurate statistical plans that are clear and understandable to the reviewers. Explains the rationale of the statistical methods to the project team.

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Study Preparation: Meets with CRA, R&D, Instrumentation scientists, department data collection programmers, and data entry to find the best way of capturing the data. Reviews the study protocol; understands the protocol; and ensures that the correct data is being collected to achieve the objective(s) of the protocol. Includes data management in the planning for the study. Makes data management aware of the schedule and any special manual data entry that will be required. Completes the study documentation that is required. Reviews all case report forms (CRFs) for completeness, accuracy, and appropriateness. Attends and participates in the team meetings.

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Data Analysis: Writes SAS and R code for common statistical analyses. Understands and correctly uses validated SAS macros and R code in the data analysis programs. Understands program verification procedure; writes and executes program verification plans. Conducts thorough and detailed reviews of project documentation, program algorithms and analysis outputs. Interprets the analysis output clearly and effectively. Identifies data analysis related issues and resolves promptly

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Post Analysis Activities: Participates in the creation of the verification plan and line listings. Prepares and reviews statistical sections contained in submissions and other publications. Prepares statistical summaries in a timely manner for team and management review. Files documents and archives projects according to current department procedures.

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Biostatistics Project Management: Successfully troubleshoots data issues. Prepares for data reviews throughout the study. Creates a realistic timeline, and adheres to the timeline. Attends team meetings regularly. Participates in the discussions. Follows the appropriate operating procedure required within the division and department. Effectively communicates information to supervisor and team members regarding the progress of the study. Explains the rationale of the statistical methods to the project team.

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Develops experimental design and performs statistical analyses for studies. Participates on project teams. Performs R and SAS programming to generate analyses of data. Responsible for implementing and maintaining the effectiveness of the quality system.

Qualifications and Skills:
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B.S. Statistics (or related field). MS/PhD in Statistics is preferred.

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Must have 2 year’s experience.

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Some experience in diagnostics and/or Quality Engineering is preferred.

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R and SAS programming

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Statistical writing

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Must have data analysis experience.

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Knowledge of regulations and standards affecting IVDs and Biologics.

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