Test Method Development & Statistics Expert – Combination Products (m/f/d)

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

Benefits dieser Stelle

LinkedIn Learning access

Reka Card contribution 20%, CHF 2,400/

Annual fitness contribution CHF 400

5 weeks vacation (40h week)

Zusammenfassung

Aequor Consulting GmbH in Basel is seeking an experienced Test Method Development & Statistics Expert for drug-device combination products. You will support R&D with analytical method development, statistics, and optimized sampling strategies in a highly regulated environment.

The role requires advanced statistical expertise, proficiency with Minitab, and fluency in English to coordinate across the project portfolio within European working hours.

Qualifikationen

• Extensive expertise in ISO standards, the European Pharmacopoeia and USP.
• Experience determining sample sizes and sampling plans per ISO 3951-2.
• Strong analytical method development experience for drug-device products.

Aufgaben

• Develop analytical methods for drug-device combination products, incl. validation and transfer per guidelines and standards.
• Create sampling plans with scientific justifications to minimize and harmonize sample quantities.
• Serve as the primary contact for statistical challenges, esp. non-normal distributions and data transformations.
• Lead initiatives to reduce the need for normality testing in projects.
• Create internal guidelines for reduced sampling plans with solid justifications.
• Provide statistical support for Health Authority responses when needed.

Kenntnisse

Statistical analysis

Experimental design

Method development

Regulatory liaison

English communication

Tools

Minitab

Jobbeschreibung

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 Test Method Development & Statistics Expert – Combination Products (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.
• Contract Date: 01.01.2027-31.12.2027 with a possibility of further extension

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 is considered an advantage.
• Availability during European working hours to ensure effective coordination of work packages and project status updates.
• 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.