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

Aequor Consulting; Basel; On-site; CHF 90,000 - 130,000; Full time

Benefits offered by this job

LinkedIn Learning access

Reka Card contribution

5 weeks vacation

Professional certifications funding

Job summary

Aequor Consulting in Basel is seeking an experienced Method Developer & Statistical Expert to support analytical method development and statistical evaluations for drug-device combination products in a highly regulated setting.

You will develop sampling plans, justify sample quantities, and address statistical challenges across projects, ensuring robust, scientifically sound results. Fluency in English is required.

Qualifications

• Extensive expertise in ISO standards, Ph. Eur. and USP and their practical use.
• Strong background in sample size determination and sampling plans per ISO 3951-2.
• Experience in analytical method development for drug-device combination products.
• Knowledge of method validation and transfer processes.
• Advanced statistics skills including data transformations; familiarity with Minitab.

Responsibilities

• Develop analytical methods for drug-device combination products, including validation and transfer.
• Design sampling plans with scientific justification to harmonize sample quantities.
• Lead statistical discussions on non-normal data and data transformations.
• Drive initiatives to reduce need for normality testing in projects.
• Create internal guidelines for reduced sampling plans with solid justification.
• Support Health Authority requests with statistical input as needed.

Skills

Analytical method development

Statistical expertise

Minitab experience

English communication

Tools

Minitab

Job description

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

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.
• 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.