Method Developer and Statistical Expert Support (m/w/d)

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