Manager, Biostatistics Systems
Careers with a passion for life.
As the world's leading medical technology company, we provide lifelong solutions to people with chronic disease. We also are dedicated to the total well being of our employees and have been recognized as a Fortune "Best 100 Companies to Work For in America." Work with the kind of people who not only love what they do but why they do it.
Purpose: This position reports directly to the Director of Corporate Statistical Resources (CSR) and is responsible for consultation and analysis that require broad statistical knowledge, methodological innovation, and implementation. The objective is to provide leadership and support in the use of efficient statistical methods throughout Medtronic in areas such as clinical studies and quality systems.
Responsibilities: · Provide consulting for all divisions of Medtronic · Provide statistical consultation for industrial/clinical applications · Statistical SOPs · Study/test protocol · Sample size determination · Sampling plans for manufacturing processes · Provide statistical consultation to the facilities/divisions of Medtronic that do not have a biostatistician · Develop statistical guidelines and procedures that can be shared throughout Medtronic, and assist Medtronic facilities for their successful implementation · Evaluate statistical aspects of clinical studies: design, conduct and analysis · Examine methodology, with respect to the study objectives, and regulatory requirements · Review statistical plans in clinical study protocols · Review clinical study submissions · Compile deficiencies/best practices and publish guidance documents · Train Medtronic technical employees in statistical methods o Develop statistical training materials · Modify course presentations to target trainee's needs · Coordinate and communicate biostatistics activities and news · Annual biostatistics meeting · Biostatistics Management Forum · Represent biostatistics expertise for Medtronic · Provide support in Bayesian and Interim Monitoring methods · Work with FDA/Industry work groups on biostatistics issues.
Requirements: · PhD in Biostatistics or equivalent · 10+ years statistical consulting experience · Teaching in clinical/industrial statistics · 5+ years experience with PMA or NDA · Oral, written interpersonal skills · Project management skills · Problem-solving skills · Facilitation skills · Knowledge of clinical regulatory requirements · Statistical skills in SAS, Design-Expert and Winbugs
With people like you, who have purpose, potential and passion, we'll supply physicians and their patients around the world with the means to extend life, restore health and alleviate pain.
To route your resume directly to the hiring department, visit www.medtronic.com/jobopportunities/ and apply for Req. No. 31731. No agencies or phone calls, please.
Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.