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Philips

3.3 | Andover, MA | Hospital & Health Care | 10000+ Employees
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Posted 2 months ago on Oct. 3, 2019

Principal Biostatistician

Full-time in San Diego, CA
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See at-a-glance how well companies like Philips support the things that are important to you.
Paid Time Off
4.0
Flexible Work Hours
3.8
Ability to Telecommute
3.8
The People You Work With
3.7
Wellness Initiatives
3.6
Philips is a hospital & health care company headquartered in the Andover, MA area with 10000+ employees. Philips has a 3.3-star InHerSight Score, based on 1,084 ratings from 75 current or former employees. 23 employees have left comments about their experience working for the company on InHerSight.

Job Title

Principal Biostatistician

Job Description

In this role, you have the opportunity to

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.

This role will specifically support our IGTD (Image Guided Therapy Devices) which include Coronary & Peripheral devices.

You are responsible for:

As a Principal 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. 

  • Lead biostatistics activities (Design, Interpretation, Infrastructure).
  • Oversee, mentor, and help develop group of internal Biostatisticians and Consultants.
  • Lead protocol development with an emphasis on study design and sample size calculations.
  • Lead in Statistical Analysis Plan development and management.
  • Lead in CRF and database specification development in conjunction with programming and data management.
  • Lead in the review and development of tables, listings, and figures as specified in the Statistical Analysis Plan.
  • Lead with the creation of ad hoc analyses and summaries as requested.
  • Provide data cleaning support for the data management effort.
  • Involved in the QC of all the deliverables created by programming and statistics (e.g. output, the statistical section in the study report).
  • Build successful relationships and seamless interfaces at the protocol / project team level, and provide timely and effective communication to the study team / trial manager and functional leads.
  • Provide input for the technical infrastructure of the biostatistics function.
  • Develop and implement strategy for the improvement of productivity and standardizing of biostatistical activities.
  • Lead in developing, applying and promoting consistent standards through standard processes and SOPs.
  • Ensure guidelines and specifications regarding statistical practices are followed, and ensure the maintenance of appropriate documentation.
  • Interface closely with Statistical Programming and Data Management on the project level.
  • The ability to travel up to 15% of time.

You are a part of:

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

To succeed in this role, you should have the following skills and experience

  • MS or PhD in Statistics/Biostatistics, or an equivalent degree with 2+ years’ experience as a statistician in device/pharma industry
  • Medical Device experience is required
  • Experience interacting with the FDA in face to face meetings (i.e. pre submission or panel meetings) is ideal
  • Experience 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

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

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 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.

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