h3Method Developer and Statistical Expert Support / no-091 /h3pFor our customer located in Basel/Switzerland we are currently looking for ab: Method developer and statistical Expert support /b(m/f/x) /pulliBranch: Pharma /liliDuration: /liliContract: Freelance. If you’re located in Switzerland it’s also possible to get employed by us (swiss payroll) /li /ulh3Tasks Responsibilities /h3ulliDevelopment of analytical methods for drug device combination products, validation and transfer activities based on Novartis internal guidelines as well as international guidelines. /liliCreation of sampling plans and scientific justification to minimize and harmonize the amount of samples /liliFirst contact for trouble shooting in terms of non-normal distribution and further data transformation for Novartis project portfolio is needed /liliLead and work on reduction of normality check of data for a “standard” project. /liliCreation of novartis internal guideline for reduced sampling plans with scientific justification /liliSupport Health Authorities requests from a statistical point of view if required /li /ulh3Must Haves /h3ulliExpert on ISO norms, European Pharmacopeia (Ph. Eur.) and United States Pharmacopeia (USP), their interpretation and application. /liliExpert for Sample size sampling plans with fixed patient risk and acceptance quality limit (AQ’s) based on ISO 3951-2 /liliExpert in method development in drug device combination product area (physical mechanical tests) as well as very solid knowledge in the field of method validation and transfers /liliStatistic expert for normal distribution and data transformation by applying statistical software (e.g. Minitab) /liliEnglish-speaking (excellent verbal and written) /li /ulpSpecific requirements: /pulliaccess to NRV, 1-QEM (Novartis internal systems) preferable /li /ulpKindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required. /ph3Employment Type /h3pFreelance or CH-Payroll /pp100% /ph3Start /h3 h3End /h3 h3Total Hours /h3p1920 /ph3Deadline /h3p :00 am /p #J-18808-Ljbffr
Method Developer and Statistical Expert Support / no-091 Arbeitgeber: SimplyVision GmbH
Unser Unternehmen bietet eine dynamische und innovative Arbeitsumgebung in Berlin, die es Ihnen ermöglicht, Ihre Fähigkeiten als Product Owner in einem agilen Team voll auszuschöpfen. Wir fördern eine offene Kommunikation und Zusammenarbeit, während wir gleichzeitig individuelle Wachstumschancen und Weiterbildungen anbieten, um Ihre Karriere voranzutreiben. Mit der Möglichkeit, remote zu arbeiten und gelegentlich vor Ort in Berlin oder Brüssel zu sein, genießen Sie die Flexibilität, die Sie benötigen, um Beruf und Privatleben in Einklang zu bringen.
