Senior Method & Statistics Expert - Drug-Device Analytics

Aequor Consulting; Basel; On-site; CHF 90,000 - 130,000; Full time

Benefits offered by this job

LinkedIn Learning access

Reka Card contribution

5 weeks vacation

Professional certifications funding

Job summary

Aequor Consulting in Basel is seeking an experienced Method Developer & Statistical Expert to support analytical method development and statistical evaluations for drug-device combination products in a highly regulated setting.

You will develop sampling plans, justify sample quantities, and address statistical challenges across projects, ensuring robust, scientifically sound results. Fluency in English is required.

Qualifications

• Extensive expertise in ISO standards, Ph. Eur. and USP and their practical use.
• Strong background in sample size determination and sampling plans per ISO 3951-2.
• Experience in analytical method development for drug-device combination products.
• Knowledge of method validation and transfer processes.
• Advanced statistics skills including data transformations; familiarity with Minitab.

Responsibilities

• Develop analytical methods for drug-device combination products, including validation and transfer.
• Design sampling plans with scientific justification to harmonize sample quantities.
• Lead statistical discussions on non-normal data and data transformations.
• Drive initiatives to reduce need for normality testing in projects.
• Create internal guidelines for reduced sampling plans with solid justification.
• Support Health Authority requests with statistical input as needed.

Skills

Analytical method development

Statistical expertise

Minitab experience

English communication

Tools

Minitab

Job description

Aequor Consulting in Basel is seeking an experienced Method Developer & Statistical Expert to support analytical method development and statistical evaluations for drug-device combination products in a highly regulated setting.

You will develop sampling plans, justify sample quantities, and address statistical challenges across projects, ensuring robust, scientifically sound results. Fluency in English is required.