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.

• Responsible for implementing and maintaining the effectiveness of the quality system.

• 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

• 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

• 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

• 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

• 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 R and SAS programming to generate analyses of data
• Responsible for implementing and maintaining the effectiveness of the quality system

• 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 years’ experience or MS/PhD in Statistics (or related field)

• R and 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.