Sr. Biostatistician for Medical Device Company in Irvine, CA

From sasCommunity

Edwards Lifesciences (NYSE: EW) is a global leader in products and technologies to treat advanced cardiovascular disease, the global leader in acute hemodynamic monitoring and the number-one heart valve company in the world. Headquartered in Irvine, California, Edwards has more than 5,000 employees’ worldwide, selling medical technologies in more than 100 countries. Edwards Lifesciences leverages its research, design, development and marketing expertise through five main product categories: Heart Valve Therapy, Critical Care, Cardiac Surgery, Vascular Therapy, and Transcatheter Valve Interventions.

For us, saving lives is not just a slogan; it's what we do. From developing devices that keep a heart pumping to creating new technologies which monitor vital signs in the critical care setting, we help ensure that patients regain and even improve their quality of life. ________________________________________

Sr. Biostatistician

Be a part of a cutting edge biostatistical group at an industry leader in medical devices. We strive to combine the latest methodology and programming techniques to design groundbreaking clinical trials and to perform state of the art analyses. Join us as we push the statistical envelope to provide our patients and physician partners with pioneering treatments in the fight against cardiovascular disease!

Opportunity Snapshot:

Contribute to the development and documentation of clinical study protocols, having the primary responsibility for developing the statistical section of the protocols.

Provide quality review of the statistical analysis plan to ensure consistency with the protocol and adequacy to meet objectives defined in protocol. Support novel analytical methods, perform complex SAS programming and address all study program issues.

Generate statistical summary tables, graphs and reports using SAS for regulatory submissions, conference presentations, and/or marketing publications.

Provide consultation to clinical project team on any statistical issues related to trial conduct.

The staff biostatistician will play a leading role in application of statistical and research methodological principles for the design, execution and analysis of clinical trials, and for ensuring the data analysis activities are conducted in accordance with regulatory and company standards.

Our Requirements:

• Multi-level position: Position title and level posted is preferred. However, we will consider hiring at the Staff Biostatistician level.

• The Senior Biostatistician position requires a minimum of two years of statistical methods experience within the pharmaceutical, biotechnology, or medical device industry with a PhD in biostatistics or statistics or a minimum of five years of statistical methods experience within the pharmaceutical, biotechnology, or medical device industry with a master's degree in biostatistics or statistics.

• The Staff Biostatistician position requires a Ph.D. in biostatistics or statistics with a minimum of five years statistical methods experience within the pharmaceutical, biotechnology, or medical device industry.

• Knowledge and skills of SAS and PC applications software are required. Experience with the UNIX operating as well as with other statistical software such as S-plus/R is a plus.

How to Apply:

At Edwards Lifesciences, we want you to have as much information as possible before making an important career decision. To find out more about this role and the opportunity it offers, please visit our website: www.edwards.com

OR

To apply directly to this position, please click the link below or cut and paste it into your browser: Sr. Biostatistician req.# 2539