In this role, you have the opportunity to
Ensure design, data analysis and interpretation by Philips for the purpose of research (particularly regulatory and marketing claim substantiation, during clinical evaluations, studies, and trials) is high quality and in compliance with regulatory body standards.
You are responsible for
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.
You are a part of
Global Clinical and Medical Affairs. The position will report into Head of Regulatory, Clinical & Medical Affairs-Greater China and dotted line report into Global Head of Biostatistics and Data Management.
To succeed in this role, you should have the following skills and experience
MS Degree in the Biostatistics discipline with a minimum of 3 years of experience in the device / pharma industry.
Experience with Base SAS, SAS/STAT, SAS Macro language, SAS/GRAPH, and in general excellent computer skills.
Coding dictionary experience preferred.
Strong communication skills, both verbal and written.
Strong scientific background and understanding of clinical trials, pharmaceutical / device operations, and regulatory compliance.
Practical knowledge of ICH, NMPA Medical Device, and GCP regulations and guidelines.
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 implicit.
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 market-based 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.
A professional but fun workplace, A healthy work-life balance environment;
An energetic, genuine, inventive, supportive and dynamic team atmosphere;
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .