Senior Test Method & Statistics Expert — Drug-Device (Basel)

Aequor Consulting GmbH; Basel; On-site; CHF 120,000 - 180,000; Full time

Benefits offered by this job

LinkedIn Learning access

Reka Card contribution 20%, CHF 2,400/

Annual fitness contribution CHF 400

5 weeks vacation (40h week)

Job summary

Aequor Consulting GmbH in Basel is seeking an experienced Test Method Development & Statistics Expert for drug-device combination products. You will support R&D with analytical method development, statistics, and optimized sampling strategies in a highly regulated environment.

The role requires advanced statistical expertise, proficiency with Minitab, and fluency in English to coordinate across the project portfolio within European working hours.

Qualifications

• Extensive expertise in ISO standards, the European Pharmacopoeia and USP.
• Experience determining sample sizes and sampling plans per ISO 3951-2.
• Strong analytical method development experience for drug-device products.

Responsibilities

• Develop analytical methods for drug-device combination products, incl. validation and transfer per guidelines and standards.
• Create sampling plans with scientific justifications to minimize and harmonize sample quantities.
• Serve as the primary contact for statistical challenges, esp. non-normal distributions and data transformations.
• Lead initiatives to reduce the need for normality testing in projects.
• Create internal guidelines for reduced sampling plans with solid justifications.
• Provide statistical support for Health Authority responses when needed.

Skills

Statistical analysis

Experimental design

Method development

Regulatory liaison

English communication

Tools

Minitab

Job description

Aequor Consulting GmbH in Basel is seeking an experienced Test Method Development & Statistics Expert for drug-device combination products. You will support R&D with analytical method development, statistics, and optimized sampling strategies in a highly regulated environment.

The role requires advanced statistical expertise, proficiency with Minitab, and fluency in English to coordinate across the project portfolio within European working hours.