)
)
Method Developer and Statistical Expert Support (M/F/D)
Tasks:
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 neede
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
Qualification:
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)
Specific requirements: English-speaking (excellent verbal and written), access to NRV, 1-QEM (Novartis internal systems) preferable, European working hour preferred (for alignment on working packages and status)
Requirements:
Start: 01.01.2027
Duration: 12 months
Capacity: 5 days per week (Campus 50% - Remote 50%)
Location: Basel, Switzerland
)