As our (Bio)Statistician, you will be working very closely and directly with scientists and engineers on our core projects across our R&D portfolio. You will be a critical contributor for the team and will lead statistical support and analysis for all of the quality and regulatory activities within the company. This includes sampling strategies, investigation plans, product performance data analysis, clinical trials, stability trials and validations. You will have a responsibility to ensure that results are interpreted correctly, and to advise project teams and decision makers on the conclusions that can be drawn.
You will need to make sure that all relevant data collection, analysis and review activities are carried out to a high standard and can be both audited and defended.
All the activities of the statistician follow the requirements of ISO 13485 and 21 CFR 820.
As a key member of the Quality team you are a leader and a champion of design controls and data integrity.
You will report to the VP Clinical Development and Regulatory Affairs.