Method Developer & Statistical Expert

Aequor Consulting GmbH; Basel; Vor Ort; CHF 120.000 - 180.000; Teilzeit

Benefits dieser Stelle

5 weeks vacation (40h)

LinkedIn Learning access

Certifications support

Card contribution CHF 2400

Fitness allowance CHF 400

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

ISO standards

Sample size determination

Analytical method development

Method validation

Statistical analysis

Minitab

English proficiency

NRV access

Tools

Minitab

Jobbeschreibung

Method Developer & Statistical Expert

Aequor Consulting GmbH Vacant since : 04.11.2026 4057 Basel (BS) 80% - 100% By agreement Temporary

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.
• Card contribution of 20%, up to CHF 2,400 per year.
• Annual fitness contribution of CHF 400.

• Aequor Consulting GmbH
  Haltingerstrasse 101
  4057 Basel

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• Work location 4057 Basel (BS)
• Workload 80% - 100%
• Employment start By agreement
• Employment duration Temporary
• By online Online form