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

Aequor Consulting GmbH

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Basel, BS, Switzerland
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Your applicationOpen nowMethod Developer & Statistical Expert (m/f/d)Aequor Consulting GmbH · Basel, BS, Switzerland
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This job: posted yesterday

The posting

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\. j4id10471188jm j4it1145jm j4iy26jm

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