For our customer located in Basel/Switzerland we are currently looking for a: Method developer and statistical Expert support (m/f/x)
- Location: Basel, Switzerland (50% onsite, 50% remote)
- Workload: 100%
- Branch: Pharma
- Duration: 01.01.27-31.12.27
- Contract: Freelance. If you’re located in Switzerland it’s also possible to get employed by us (swiss payroll)
Tasks & Responsibilities
- Development of analytical methods for drug device combination products, validation and transfer activities based on Novartis internal guidelines as well as international guidelines.
- Creation of sampling plans and scientific justification to minimize and harmonize the amount of samples
- First contact for trouble shooting in terms of non-normal distribution and further data transformation for Novartis project portfolio is needed
- Lead and work on reduction of normality check of data for a “standard” project.
- Creation of novartis internal guideline for reduced sampling plans with scientific justification
- Support Health Authorities requests from a statistical point of view if required
Must Haves
- Expert on ISO norms, European Pharmacopeia (Ph. Eur.) and United States Pharmacopeia (USP), their interpretation and application.
- Expert for Sample size sampling plans with fixed patient risk and acceptance quality limit (AQ’s) based on ISO 3951-2
- Expert in method development in drug device combination product area (physical & mechanical tests) as well as very solid knowledge in the field of method validation and transfers
- Statistic expert for normal distribution and data transformation by applying statistical software (e.g. Minitab)
- English-speaking (excellent verbal and written)
Specific requirements:
- access to NRV, 1-QEM (Novartis internal systems) preferable
- European working hour preferred
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.
