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Method Developer & Statistical Expert (m/f/d) – Basel | JobRevolt

Über den Job

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.

Aufgaben

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.

Profil

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.

Rahmenbedingungen

Pensum: 40-hour working week
Ort: Basel

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.

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

Über den Job

Über den Job

Aufgaben

Profil

Rahmenbedingungen

Benefits

Skills

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