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WHAT
IN
Statistician
Job
Medtronic
US
-
Minneapolis,
Minnesota
Job Code - 68936
Position - Full Time - Regular
Job First Active on: Monday, October 26, 2009
APPLY TO THIS JOB (You will be applying directly to Medtronic for this position!)
JOB DESCRIPTION: Statistician
The Statistician will be responsible for statistical aspects of study design and analysis of data from clinical studies conducted for regulatory approval or marketing purposes. This includes responsibility for design of studies, calculating of sample size and power, writing of statistical portions of protocol and statistical analysis plan, review of protocol and case report forms, analysis and interpretation of data, and preparation of relevant sections of regulatory submissions, reports, and manuscripts. Work and progress toward objectives will generally be reviewed on a regular basis by the Manager.
REQUIREMENTS - QUALIFICATIONS: Statistician
Applies statistical knowledge to the design of clinical studies, ensuring that study objectives can be met. This requires calculation of sample size and power, as well as solicitation of appropriate design assumptions from other staff and from published literature.
Prepares relevant sections of protocols, especially those detailing the plans for data analysis, and justification for the sample size. Reviews entire protocol for consistency.
Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately.
Identifies potential threats to study credibility and validity, and works with study team to prevent, track, and manage potential problems.
Writes the statistical analysis plan for the study, if required. Also writes error-checking requirements for the study data.
Assists study team in responding to questions from FDA.
Uses a variety of statistical methods and software tools to analyze and display data from clinical and other studies. Methods must be appropriate for the kind of data collected, and required assumptions must be tested.
Interprets statistical findings, and ensures that regulatory submissions, reports, and manuscripts accurately reflect the data collected.
Validates and provides clear documentation of analysis programs.
Writes portions of Results and Methods sections of reports and manuscripts.
Consults with other (e.g. non-clinical) staff on statistical and analysis issues.
Attends and contributes to project and department meetings.
KNOWLEDGE/EDUCATION
Masters degree in Biostatistics or Statistics. A Bachelor’s degree may be considered if the applicant is nearing completion of their graduate degree.
JOB EXPERIENCE
Experience and/or education in analysis of data from clinical studies.
SKILLS/COMPETENCIES
Strong applied statistical skills.
SAS programming skills
Experience with or education in principles of research data management
Competency in Windows environment and with Microsoft Office Tools (Word, Excel)
Medtronics
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