Statistician II

Boston Scientific (NYSE: BSX) is a worldwide developer, manufacturer and marketer of medical devices.

This Statistician role will perform advanced statistical analyses using product complaints data in order to monitor BSC product performance. This role will have additional responsibilities to develop advanced statistical tools and programs to support quality processes and analytics. The team uses product performance data to escalate post-market field performance signals into the CAPA process in collaboration with Return Device Analysis, R & D, Design Assurance, Medical Safety and the CAPA Management teams. This role provides for significant visibility across the quality organization.

Serve as an internal resource to the site in statistical techniques.

• Provide technical expertise and internal support to the site on the use of statistical methods associated with hypothesis testing, statistical process control, and survival analysis.
• Perform needed statistical analysis by identifying needs, partnering with other groups or departments, and performing calculations.
• Present interpreted statistical analyses and results by preparing and delivering both written analyses and verbal presentations.
• Development, documentation, and testing of analysis data and programming code to meet regulatory and company standards.

Quality System Requirements

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Basic Qualifications:

• BS in Statistics, Biostatistics or related field with 2-4 years of relevant experience OR MS with 0-2 years of relevant experience
• Expertise in a broad range of statistical techniques, including power and sample size calculations, hypothesis testing, statistical process control, and survival analysis.
• Experience developing and performing statistical analysis utilizing software packages such as SAS, R, Minitab or Microsoft Excel required.

Preferred Qualifications:

• Experience in a regulated environment such as medical devices or pharmaceuticals.
• Experience developing applications using machine learning, natural language processing (NLP) or text mining tools and methodologies.
• Experience with using business intelligence (BI) and visualization tools.