Senior Method & Statistics Expert for NV R&D (Freelance)

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

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.