Method developer and statistical Expert support for NV R&D / no

For our customer located in Basel, Switzerland we are currently looking for a: Method developer and statistical Expert support for NV R&D (m/f/d)

• Duration: 04.01.27 – 31.12.27
• Workload: 100%
• Location: On site - NV Basel Campus 50% - Remote 50%
• Gross Rate Range (given by client): 40-41 chf/h gross. Typical monthly salary, e.g. 160h*41chf/h=6.560 chf gross
• 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