Method Developer & Statistical Expert (m/f/d)

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

Are you an experienced analytical method development and statistics expert with a strong background in pharmaceutical drug-device combination products? Do you have in-depth knowledge of international standards and statistical methodologies, and enjoy applying your expertise to improve analytical processes and ensure robust, scientifically sound results?

For a leading international pharmaceutical company in Basel, an experienced Method Developer & Statistical Expert (m/f/d) is sought to support Research & Development activities. This assignment offers the opportunity to contribute to analytical method development, statistical evaluations and the optimization of sampling strategies within a highly regulated environment.

Responsibilities

• Develop analytical methods for drug-device combination products, including 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.

Requirements

• Extensive expertise in ISO standards, the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP), including their interpretation and practical application.
• Proven expertise in sample size determination and sampling plans based on fixed patient risk and Acceptance Quality Limits (AQL), particularly in accordance with ISO 3951-2.
• Strong experience in analytical method development for drug-device combination products, particularly physical and mechanical testing.
• In-depth knowledge of analytical method validation and transfer processes.
• Advanced statistical expertise in normality assessment and data transformation, including practical experience with statistical software such as Minitab.
• Excellent verbal and written English communication skills.
• Experience with or access to NRV and 1-QEM (Novartis internal systems) is considered an advantage.
• Availability during European working hours to ensure effective coordination of work packages and project status updates.

Benefits

• 5 weeks of annual vacation based on a 40-hour working week.
• Access to LinkedIn Learning with more than 5,000 online courses.
• Financial support for professional certifications and further education.
• Reka Card contribution of 20%, up to CHF 2,400 per year.
• Annual fitness contribution of CHF 400.