Job TitleSenior Biostatistician
Your role will provide statistical support to the office of Global Clinical Affairs. The statistical support (e.g., study design and data analysis) will be leveraged broadly across all Philips entities to support clinical, pre-clinical, and validation studies and data mining for a) product development; b) global regulatory submission; c) claims substantiation d) post market surveillance, and tracking data optimization. These activities are in direct support of product approval of Philips’ most innovative technologies and claim support.
As a Senior Biostatistician you will assist with a variety of statistical activities such as design, analysis and reporting of studies for both regulatory submission and claim support, and data mining across all Philips Business Units.
Key areas of responsibility:
- Assist with the design and analysis of medical device clinical trials in humans
- Perform statistical analysis and validate as defined in analysis plan
- Assist with preparation of analyses that support Regulatory submissions for product approval
- Provide under detailed supervision statistical support for peer-reviewed journal publications
- Deliver results in a manner that is time-sensitive, high quality, proactive and communicative with collaborating entities and Stakeholders
- Perform sample size and power calculations
- Assist in review of CRFs and edit checks
- Review and understand analysis plans
- Write interpretation of results with oversight from supervisor
- Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.
- Work with data Management partners to organize timely and accurate data extraction from EDC (or other) system into statistical programs for analysis.
You will report directly to the Director of Biostatistics. Your team works together with other functions within Global Clinical Affairs to serve the needs of the different Philips Business Units.
Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Headquartered in the Netherlands, Philips’ health technology portfolio generated 2015 sales of EUR 16.8 billion and employs approximately 69,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
We are looking for
- MS or PhD in Statistics/Biostatistics, or an equivalent degree with 2+ years’ experience as a statistician in device/pharma industry
- Expert level use with Statistical software, including SAS
- Proven ability in the use of EDC/CTMS databases
- Knowledge of applied statistics for the purposes of Regulatory submission, claims substantiation and peer-reviewed publications
- Basic knowledge of Global Regulatory Requirements and Standards for statistical applications in the conduct of Clinical Research
- Well-developed interpersonal relationship skills
- Proven ability to take independent action to initiate process improvement, when needed
- Proven ability to work in a matrix-like manner where cross-functional interaction is an implicit Way of Working
- Proven ability to deliver on delegated work efficiently
- Solid time-management skills to meet deliverables commensurate with a fast-paced environment
- Well organized, able to multitask and prioritize competing tasks
- Able to manage expectations with supervisors, peers and customers
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.
In case of difficulties with your job application please send an email to [email protected]
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