Saint Paul, MN

What you'll be doing

Primary focus of a statistician will be on the design and evidence dissemination of clinical studies. Ensure clinical protocols and statistical methods meet sound and efficient statistical and clinical trial methodologies. Work with cross-functional teams to develop and refine study objectives to establish the safety and efficacy of medical device therapies and diagnostics. Participate in development and documentation of study protocols with responsibility for scientific soundness sections, which include statistical hypotheses, sample size calculations, and analysis methods for meeting the study objectives, in collaboration with others. Stay current on clinical evidence landscape and oversee dissemination efforts of abstracts, oral and poster presentations, reports and publications. Interact with FDA reviewers, especially statistical, to negotiate appropriate study designs, to explain the quantitative results of clinical studies and to defend the analytical approach. Actively participate with internal and external governing bodies of clinical trials (e.g. steering, publications committees, etc.). Mentor and train other statistician job duties and responsibilities. Remain current on state of the art statistical methods useful in clinical trial design and analysis and share knowledge within the department. Lead development of policies and procedures for the department and the statistics group. Perform statistical program validation of important endpoints in accordance with departmental standard operating procedures. Identify potential threats to study credibility or validity and work with study teams to prevent, track and manage potential problems. Review statistical analysis plans. Review case report forms and ensure consistency between the data collected and the objectives of the study.

What your background should be

This position required minimum 7 to 11 years of experience in the design and analysis of clinical studies. Advanced programming skills in SAS. Knowledge of clinical trial methods and execution in a regulated environment. Demonstration of strong oral and written communication skills, including experience presenting clinical trial results and statistical methods.

Required Schooling / Training

MS in Statistics, Biostatistics or related field. PHD preferred.

Who is the client company

A leading American staffing agency operates throughout the world.
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