Method Developer and Statistical Expert Support

K-Recruiting GmbH; Schweiz; Hybrid; CHF 90,000 - 120,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

ISO norms expertise

Pharmacopeia knowledge

Statistical methods

Analytical method development

English skills

Tools

Minitab

Job description

Method Developer and Statistical Expert Support (M/F/D)

Tasks:

• 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

Qualification:

• 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)

Requirements:

Start: 01.01.2027

Duration: 12 months

Capacity: 5 days per week (Campus 50% - Remote 50%)

Location: Basel, Switzerland