BIOSTATISTICIAN, Emerging Businesses BG
This role is a unique leadership opportunity to build statistical capabilities across the newly formed Emerging Businesses Business Group (BG), and support the BG succeed in delivering on its mission, vision and strategy. You will lead in the development and application of innovative statistical methodologies and designing statistical analysis plans for new and transformational "in vitro diagnostics" (IVD) and medical device solutions, supporting all of the Businesses within the EB BG. You are viewed as an expert in the field of biostatistics. This role will report to the Head of Quality & Regulatory, Clinical & Medical Affairs for the Emerging Businesses Business Group, and sit on their leadership team.
You will be responsible for developing and applying innovative statistical methodologies and designing statistical analysis plans for new and transformational "in vitro diagnostics" (IVD) and medical device solutions, supporting all of the Businesses within the EB BG. You are viewed as an expert in the field of biostatistics. Your responsibilities include:
- Leading statistical aspects of regulatory submissions from design of clinical studies to analysis and reporting of results for all types of global regulatory submissions including 510(k)s and PMAs, and also post-market clinical follow up
- To ensure that all clinical development efforts are conducted with appropriate statistical planning, maintains systems to monitor and maintain data and analytic integrity, and provides statistical interpretation of study results as per committed project time lines.
- Provide leadership in establishing and maintaining policies, standards, and guidance's for biostatistics and data management operation
- Responsible for providing appropriate statistical and data management resources for the strategy and design of clinical development plans. The position supervises both in-house and CRO activities related to data capture and management, statistical programming, and application of statistics to clinical trials data.
- Represent Philips in meetings with regulatory agencies and prepare oral/written responses to statistical questions raised by regulatory agencies
- Interpretation of data and reporting, including clinical study reports and co-authoring manuscripts t in drafting peer-reviewed journal articles
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that's not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role's mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
- We are looking for
- 5+ years' experience in a statistics role with a strong preference for medical device industry, and in particular, in vitro diagnostics expertise
- Expert knowledge of statistical methodology, applied statistics for the purposes of regulatory submission, claims substantiation and peer-reviewed publications
- Reads, understands, and articulates interpretation of results
- In depth understanding of regulatory requirements (FDA, PMA, ICH, GCP, etc) for optimal pathway to product approval, and how statistics can shape and accelerate the process
- Able to write code for simple analyses and to use SAS at the expert level, knowledge of R is appreciated
- Ability to apply statistical techniques most well-suited for specific requests in a manner that ensures accurate and robust conclusions
- Open, clear and responsive in spoken and written communication
- Commitment to deadlines
- Expert knowledge of clinical data presentation standards
- Team player, willing to provide help where necessary
- Creative thinking ("out of the box") to come up with different statistical alternatives to reach the project goal
- Provide review and critical feedback of interpretation of results from other statisticians
In case of difficulties with your job application please send an email to [email protected]
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