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.