Method developer and statistical Expert support for NV R&D / no-091

SimplyVision GmbH; Basel; On-site; CHF 55,000 - 56,000; Part time

Job summary

SimplyVision GmbH seeks a freelance Method Developer and Statistical Expert for NV R&D in Basel. You will develop analytical methods for drug-device combination products, validate and transfer according to internal and international guidelines, and lead sampling plan creation with rigorous scientific justification.

The role requires expertise in ISO norms, Ph. Eur., USP, and statistical software (e.g., Minitab) with strong English communication.

Qualifications

• Expert in ISO norms, European Pharmacopeia (Ph. Eur.) and United States Pharmacopeia (USP) and their application.
• Expert for sample size sampling plans with fixed patient risk and AQ’s based on ISO 3951-2.
• Expert in method development for drug-device combination products, including validation and transfers.

Responsibilities

• Development of analytical methods for drug-device combination products and transfer activities.
• Creation of sampling plans and scientific justification to minimize samples.
• Troubleshooting non-normal distributions and data transformations for Novartis project portfolio.

Skills

ISO norms

Ph.Eur./USP

Sample size planning

Method development

Data analysis

Minitab

English proficiency

Tools

Minitab

Job description

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
• 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