Method Dev & Statistical Expert - Drug-Device Analytics

SimplyVision GmbH; Basel; Híbrido; CHF 83.000 - 138.000; Jornada completa

Descripción de la vacante

SimplyVision GmbH is seeking a Method Developer and Statistical Expert Support on a freelance basis for projects in Basel, Switzerland. The role covers analytical method development for drug-device products, data analysis, and regulatory support under Novartis guidelines.

You will lead sampling plan creation, data transformations, and statistical analyses to support project portfolios and ensure compliance with ISO, Ph. Eur., and USP standards.

Formación

• Expert on ISO norms, European Pharmacopeia (Ph. Eur.) and United States Pharmacopeia (USP).
• Expert for Sample size sampling plans with fixed patient risk and AQ’s based on ISO 3951-2
• Expert in method development in drug device combination product area (physical & mechanical tests) as well as solid knowledge in 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)

Responsabilidades

• 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 troubleshooting 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

Conocimientos

ISO norms

Sample size planning

Method development

Minitab

English proficiency

Herramientas

Minitab

Descripción del empleo

SimplyVision GmbH is seeking a Method Developer and Statistical Expert Support on a freelance basis for projects in Basel, Switzerland. The role covers analytical method development for drug-device products, data analysis, and regulatory support under Novartis guidelines.

You will lead sampling plan creation, data transformations, and statistical analyses to support project portfolios and ensure compliance with ISO, Ph. Eur., and USP standards.