- Aequor Consulting GmbH
- Basel, BS
- Full-Time
- <48 Hours
Method Developer & Statistical Expert (m/f/d).
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Method Developer & Statistical Expert (m/f/d): our view in 3 lines...
- The Role:This role is for an experienced specialist in analytical method development and statistics who supports pharmaceutical drug-device combination product work.
- The Person:The person will develop analytical methods including validation and transfer, create sampling plans with scientific justifications, troubleshoot statistical challenges across projects, lead initiatives to reduce normality testing, develop internal reduced sampling guidelines, and support Health Authority requests.
- Requirements:The ideal candidate has extensive expertise in ISO standards, Ph. Eur. and USP, proven expertise in sampling plans and sample size determination, strong experience in analytical method development, and advanced statistical expertise in normality assessment and data transformation using Minitab.
About the role
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.