In this role, you have the opportunity to
Under limited supervision the PMS Statistician is responsible for developing and implementing effective data analysis and quality and safety signals associated to post-launch monitoring of product performance in the field (e.g., adverse events, product malfunctions).
You are responsible for
Activities related Trending and Escalation:
Responsible for developing statistical methods needed to effectively monitor PMS data to assure Patient Safety and Product Quality Responsible for managing the Post Market Surveillance trending processes and assuring proper statistical techniques are applied to all trending methods Responsible for continual review of data that is used for the Trending and Escalation procedure (e.g., calculation of upper control limits). Assures the data integrity of all output via appropriate verification and validation activities. Able to work with data from the trending system and create programs in Python, R, SAS, Excel, Minitab, etc to output the data in a manner that is useful for presentation purposes. Ability to explain trending procedures during an audit, if necessary. Establishes statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
Activities related Complaint Handling:
Continuously improves Complaint Handling trend reports and reporting to meet changing needs of business. With minimal supervision, works with Philips associates from all departments, including Medical affairs, clinicians, engineers, and regulatory Affairs associates, to develop complaint reports that appropriately address questions posed. Possess the ability to work independently with minimal supervision as well as the ability to guide others in the Complaint Handling group with regard to data analysis.
May receive technical guidance on complex problems, but independently determines and develops approaches and solutions.
With some guidance, makes decisions on statistical problems and methods, and represents the organization in conferences to resolve important questions and to plan and coordinate work. Consults with supervisor concerning unusual problems and developments.
As an individual researcher, carries out assignments requiring the development of new or improved techniques or procedures.
Work is expected to result in the development of new or improved techniques or procedures.
Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, MDSAP, EUMDR, etc.
TRAVEL up to 30%
To succeed in this role, you should have the following skills and experience
Master's degree preferred in Statistical or Mathematics Sciences
Must possess understanding of engineering and statistics fundamentals.
American Society for Quality (ASQ) certification, Six Sigma knowledge is desirable.
Some experience in the Healthcare industry preferred
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.