US-MN-PaulShoreview: Statistician Neurological Clinical

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Date: 08-Jul-2008

Statistician Neurological Clinical

Position Description

The Statistician will be responsible for analysis of data from registry studies and, in addition, may be responsible for statistical aspects of study design and data analyses conducted for regulatory approval or marketing purposes. This includes responsibility for writing statistical analysis plans, analysis and interpretation of data and preparation of relevant sections of regulatory submissions, reports, and manuscripts. This may also include responsibility for design of studies, calculating of sample size and power, writing statistical portions of protocols, and review of protocols and case report forms. Work and progress toward objectives will generally be reviewed on a regular basis by the Manager.

Position Responsibilities

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. Writes the statistical analysis plan for the study, if required. Also writes error-checking requirements for the study data. 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. Assists study team in responding to questions from FDA. Attends and contributes to project and department meetings.

Basic Qualifications

Masters degree in Biostatistics or Statistics. For some positions, a Bachelor’s degree may be considered if the applicant is nearing completion of their graduate degree. Some experience in analysis of data from clinical studies. Strong applied statistical skills, including both parametric and non-parametric statistics. SAS programming skills. Familiarity with principles of research data management. Competency in Windows environment and with Microsoft Office Tools (Word, Excel). Evidence of good oral and written communication skills. Well-developed interpersonal skills.

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