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Statistician
MED Institue, Inc.
West Lafayette

Date:  8/9/2010
Position Type:  Full Time

Start Date:  Immediate Availability

Duties/Responsibilities:

This individual is responsible for working closely with the Manager, Biostatistics and Data Management and management to support the statistical needs of global projects on behalf of the Cook organization.

• Apply statistical and research methodological principles to the design, execution, analysis, and interpretation of clinical studies, as well as assist in defining the strategy for clinical studies;
• Ensure that data and statistical activities comply with regulatory and company standards;
•  Author and provide input on relevant sections of clinical research protocols and assist in the design of case report forms and databases;
• Advise the DSMB regarding safety monitoring of clinical studies, including the development of appropriate study monitoring criteria;
• Provide statistical support regarding the design and execution of bench and animal testing protocols, as well as the analysis and interpretation of data to be included in the resulting test report, if necessary;
• Provide statistical support in the development of quality systems related to the manufacturing of medical devices; and
• Maintain familiarity with company statistical software and provide custom programming for data reporting and statistical analysis.

 

Requirements/Qualifications:

• Minimum of Masters in Statistics; PhD preferred;
• Prior experience in the conduct of clinical studies, preferably in the medical device industry;
• Working knowledge of FDA and other regulatory requirements that may impact global clinical studies;
• Established relationships with other researchers, scientists and clinicians in the field;
• Conscientious, influential person with an outstanding work ethic and strong personal discipline;
• Willingness and capability to handle multiple projects and responsibilities;
• Excellent organizational, leadership and problem-solving skills;
• Excellent written and verbal communication skills; and
• Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues.

Other:
Benefits include 401k and profit sharing plans as well as health, dental, life and optical insurance, eight paid holidays per year, and vacation.

MED Institute is an Equal Opportunity Employer (EOE).

Application Instructions:

Please e-mail resume to hr@medinst.com