Lead Pharma Method & Statistics Specialist

Aequor Consulting GmbH; Basel; On-site; CHF 120,000 - 150,000; Full time

Benefits offered by this job

LinkedIn Learning access

Certifications funding

Reka Card benefit CHF 2,400/yr

Job summary

Aequor Consulting GmbH in Basel is seeking a Method Developer & Statistical Expert to support analytical method development for drug-device combination products. You will contribute to method validation, transfer activities, and statistical evaluations in a highly regulated environment.

Responsibilities include designing sampling plans, justifying sample quantities, and providing statistical expertise for Health Authority requests.

Qualifications

• Extensive expertise in ISO standards (Ph. Eur., USP) and their application.
• Proven ability in sampling plans and sample size determination per ISO 3951-2.
• Experience in analytical method development for drug-device combinations.
• Know-how in method validation and transfer processes.
• Advanced statistics with data transformations and normality assessment; familiarity with Minitab.
• Excellent written and spoken English.
• Experience with NRV and 1-QEM is a plus.
• Availability during European working hours.
• 5 weeks vacation on 40-hour week.
• LinkedIn Learning access; funding for certs; Reka Card benefits.

Responsibilities

• Develop analytical methods for drug-device products, incl. method validation and transfer activities in accordance with internal guidelines and applicable international standards.
• Develop sampling plans and provide scientific justifications to minimize and harmonize sample quantities.
• Act as the primary point of contact for troubleshooting statistical challenges, particularly regarding non-normal data distributions and appropriate data transformations across the project portfolio.
• Lead and implement initiatives to reduce the need for normality testing in standard projects.
• Develop internal guidelines for reduced sampling plans, supported by scientifically sound justifications.
• Provide statistical expertise and support in responding to Health Authority requests, where required.

Skills

Statistical methods

Analytical method development

Sampling plans

ISO standards

Ph Eur & USP knowledge

English communication

Tools

Minitab

Job description

Aequor Consulting GmbH in Basel is seeking a Method Developer & Statistical Expert to support analytical method development for drug-device combination products. You will contribute to method validation, transfer activities, and statistical evaluations in a highly regulated environment.

Responsibilities include designing sampling plans, justifying sample quantities, and providing statistical expertise for Health Authority requests.