Job Title: Senior Biostatistician
Division: Stryker Orthopaedics

LOCALE

United States - New Jersey City or Sales Region Mahwah Business Function

EDUCATION

PhD in statistics, biostatistics, or epidemiology.

DESCRIPTION

Design clinical research trials to successfully support pre-market approval of regulated products. Create statistical analysis plans and perform statistical analyses and mentor others in these tasks.

ESSENTIAL RESPONSIBILITIES

This position will have direct line management responsibilities for 3 FTEs and 2 contract staff members including SAS programmers and database developers. This person will be the only biostatistician in orthopedics and will set direction and lead staff in the development of clinical research protocol design, data collection, and analysis.
Design clinical studies using sound statistical principals strategic vision of how to achieve trial success.
Write statistical analysis plans which detail the methodologies to be used when analyzing clinical trial results.
Perform statistical analysis and oversees SAS programmers to provide database and statistical reports of the data collected.
Lead project teams to ensure data collected will support study goals and endpoints.
Act as a resource to Investigators by proposing and overseeing research initiatives.
Act as a resource to other Stryker departments such as quality and manufacturing when statistical analysis issues arise.
Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Orthopaedics Business Process Excellence initiative.

QUALIFICATIONS/WORK EXPERIENCE

Minimum 7 years experience in a Clinical Research setting.
Proven ability to design Clinical Research and analyze data which has successfully supported market approval of regulated products.
Proficiency with SAS analytical software and relational databases; SAS certification required.
Experience corresponding with Food and Drug Administration (FDA) agency and presenting to Investigators and FDA.

Percent Travel Required 10%

HOW TO APPLY

Please go to http://www.stryker.com/careers and use Requisition ID 2819BR

DEADLINE:
None