Required skills
Languages: English
Job description
Project overview
Method Developer and Statistical Expert Support (M/F/D)
Responsibilities
Qualification:
- 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
- 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)
Project details
01.01.2027
12 months
Capacity: 5 days per week (Campus 50% - Remote 50%)
Basel, Switzerland
- Start: ASAP
- Duration: 12 months
- Remote: hybrid
- Location: Basel, Switzerland, CH
- Languages: English
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