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Job Description: Statistician
Primary Job Function
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.
Core Job Responsibilities
Responsible for implementing and maintaining the effectiveness of the quality system.
Developing Statistical Plan: Effectively communicates with project manager/CRA to understand to 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.
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.
Data Analysis: Writes SAS code for common statistical analyses. Understands and correctly uses validated SAS macros 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
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.
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.
Develops experimental design and performs statistical analyses for studies. Participates on project teams. Performs SAS programming to generate analyses of data. Responsible for implementing and maintaining the effectiveness of the quality system.
Position Accountability / Scope
Accountable for proper use of statistics and for the validity of conclusions drawn. Performs the majority of tasks with minimal assistance.
B.S. Statistics (or related field) + 2 year's experience or MS/PhD in Statistics (or related field)
Minimum Experience / Training Required
SAS programming, statistical writing, experience in data analysis. Knowledge of regulations and standards affecting IVDs and Biologics. (some experience preferable diagnostics) and/or Quality Engineering experience.
Some experience preferable diagnostics and/or Quality Engineering experience.
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