Senior Method Developer & Statistics Expert – Pharma

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

Benefits offered by this job

5 weeks vacation

LinkedIn Learning

Certifications support

Reka card 20%

Fitness allowance

Job summary

Aequor Consulting GmbH in Basel seeks an experienced Method Developer & Statistical Expert to drive analytical method development for drug-device combination products within a highly regulated environment.

You will lead statistical evaluations, optimize sampling strategies, and provide expertise for method validation, transfer, and Health Authority responses across European projects. Fluent English and advanced Minitab skills are required.

Qualifications

• Expertise in ISO standards, Ph.Eur. and USP with interpretation.
• Proven sample size planning and sampling plan expertise (ISO 3951-2).
• Experience in analytical method development for drug-device products.
• Deep knowledge of method validation and transfer processes.
• Advanced statistics, normality assessment and data transformations; Minitab experience.
• Excellent verbal and written English communication.
• Experience with NRV/1-QEM is a plus.
• Availability during European working hours for coordination.

Responsibilities

• Develop analytical methods for drug-device products, incl. validation and transfer.
• Develop sampling plans with scientific justifications to minimize quantities.
• Serve as primary contact for statistical challenges and data transformations.
• Lead initiatives to reduce the need for normality testing in projects.
• Develop internal guidelines for reduced sampling plans with scientific support.
• Provide statistical expertise for Health Authority responses when required.

Skills

Statistical analysis

ISO/Ph.Eur/USP interpretation

Sample size planning

Method development

Validation & transfer

Minitab expertise

Experiment design

English communication

NRV/1-QEM access

Tools

Minitab

NRV/1-QEM access

Job description

Aequor Consulting GmbH in Basel seeks an experienced Method Developer & Statistical Expert to drive analytical method development for drug-device combination products within a highly regulated environment.

You will lead statistical evaluations, optimize sampling strategies, and provide expertise for method validation, transfer, and Health Authority responses across European projects. Fluent English and advanced Minitab skills are required.