Senior Method Developer & Statistical Expert – Drug‑Device

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

Benefits offered by this job

5 weeks vacation (40h)

LinkedIn Learning access

Certifications support

Card contribution CHF 2400

Fitness allowance CHF 400

Job summary

Aequor Consulting GmbH in Basel seeks an experienced Method Developer & Statistical Expert to support R&D in pharmaceutical drug-device combinations. You will develop analytical methods, validate and transfer methods, and optimize sampling strategies within a highly regulated environment.

The role requires ISO, Ph. Eur., USP expertise, experience with sample size planning (AQL/ISO 3951-2), and advanced statistics (Minitab). English fluency and European hours alignment are essential.

Qualifications

• Expertise with ISO standards, Ph. Eur., USP and interpreting them in practice.
• Experience in sample size planning and AQL-based approaches per ISO 3951-2.
• Strong background in analytical method development for drug-device products.
• Proven method validation and transfer experience.
• Advanced statistics with normality assessment and data transformations.
• Proficient in Minitab software; excellent English communication.

Responsibilities

• Develop analytical methods for drug-device products with validation and transfer.
• Design sampling plans and justify reduced sample quantities.
• Address statistical challenges across projects and optimize data handling.
• Lead initiatives to reduce unnecessary normality testing.
• Draft internal guidelines for reduced sampling strategies.
• Support health authority responses with statistical expertise.

Skills

ISO standards

Sample size determination

Analytical method development

Method validation

Statistical analysis

Minitab

English proficiency

NRV access

Tools

Minitab

Job description

Aequor Consulting GmbH in Basel seeks an experienced Method Developer & Statistical Expert to support R&D in pharmaceutical drug-device combinations. You will develop analytical methods, validate and transfer methods, and optimize sampling strategies within a highly regulated environment.

The role requires ISO, Ph. Eur., USP expertise, experience with sample size planning (AQL/ISO 3951-2), and advanced statistics (Minitab). English fluency and European hours alignment are essential.