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

salary Salary :

fr2,400 monthly

icon building Company : Aequor Consulting Gmbh
icon briefcase Job Type : Full Time
icon geo-alt Basel, Switzerland

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.
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.


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