Descripción
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\-dev