Hybrid Method Developer & Statistical Expert (Remote)

K-Recruiting GmbH; Schweiz; Hybrid; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Novartis Basel, Switzerland seeks a Method Developer and Statistical Expert to develop analytical methods for drug-device combination products and validate transfer activities in line with internal and international guidelines.

The role requires ISO/Ph. Eur./USP expertise, expertise in sample size planning per ISO 3951-2, and proficiency in Minitab for data transformation and normality checks. Start 01.01.2027, 12 months, 50% on campus / 50% remote.

Qualifikationen

• Expertise in ISO norms and pharmacopoeias (Ph. Eur./USP) and their interpretation.
• Expert for sample size planning with fixed risk and AQ based on ISO 3951-2.
• Experience in method development for drug-device combination products, validation and transfers.
• Statistics expert for normal distribution and data transformation using statistical software.
• Fluent English, written and spoken; NRV access helpful.

Aufgaben

• Develop analytical methods for drug-device combination products per Novartis guidelines and international guidelines.
• Create sampling plans and justify to minimize samples.
• Serve as first contact for troubleshooting non-normal distribution and data transformation.
• Lead reduction of normality checks for standard projects.
• Develop internal guidelines for reduced sampling plans with scientific justification.
• Support Health Authorities requests from a statistical perspective when required.

Kenntnisse

ISO norms expertise

Pharmacopeia knowledge

Statistical methods

Analytical method development

English skills

Tools

Minitab

Jobbeschreibung

Novartis Basel, Switzerland seeks a Method Developer and Statistical Expert to develop analytical methods for drug-device combination products and validate transfer activities in line with internal and international guidelines.

The role requires ISO/Ph. Eur./USP expertise, expertise in sample size planning per ISO 3951-2, and proficiency in Minitab for data transformation and normality checks. Start 01.01.2027, 12 months, 50% on campus / 50% remote.