Associate Director of Biostatistics and Data Management

Kip Denson • May 24, 2002

Associate Director of Biostatistics and Data Management

Worldwide leader in medical devices. Well-established company with more than 3,200 people employed around the world. The Company's Mission is to develop, produce and globally market the highest quality products and services that repair, replace and regenerate. The Company truly has a Devotion to the Employees and a reputation for employee satisfaction. People love to work here!

Principal Job Functions:

The Associate Director of Biostatistics and Data Management is responsible for assisting in protocol design, planning, preparation, and execution of all aspects of IDE clinical trials, as well as preparing analyses and presentations of post market, device outcomes studies. The incumbent plays an essential role in overseeing the operations of the clinical data management group, in producing valid experimental designs and statistical inference, and maintaining the highest standards of ethical conduct in handling regulated patient data. Primary responsibilities for Oracle Clinical database design and development, research and clinical trial statistical analysis. Some consulting opportunities exist in the areas of advanced technology, research and development, manufacturing, and quality. The position oversees the daily activities of a six-person clinical computer operations group of dedicated data management professionals, and reports to the Director of Clinical Affairs.

Qualifications:

The successful candidate for Manager, Biostatistics and Data Management should have an M.S. or Ph.D. in statistics or biostatistics and 0 to 2 years experience in pharmaceutical or device clinical trials. Comprehensive knowledge of biostatistics and experimental design is expected. The candidate should have demonstrated knowledge of SAS and other PC based statistical and database software. Oracle Clinical database software proficiency and experience with handling large databases are highly valued. Experience in consulting with medical researchers and engineers, and in preparing formal reports and regulatory submissions is highly desirable. Excellent communication and presentation skills, both written and oral, are essential. Familiarity with FDA guidelines and requirements is also preferred.

Contact:

Kip Denson
kip[at]densongroup.com
941-708-3838

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