Review key study documents produced by other functions (protocols, statistical analysis plans [SAPs], TFL shells, case report forms) and interact with Statisticians and other clinical team members to ensure programming requirements are understood. Follow SAPs, develop specifications and execute derivation algorithms for analysis dataset production. Follow the SDTM and ADa

The individual in this position will perform a variety of manufacturing technician and low level engineering design activities in support of Glaukos' ocular related products manufacturing activities. Responsibilities include building subassembly and top level assemblies for Glaukos stent systems, developing creative solutions to manufacturing problems, ensuring the proper

Quality System Interfacing with all departments to ensure the quality system is implemented and effective. Lead groups in improvement projects to ensure continued compliance of the quality system. Creating reports in Oracle Cloud and CATSWeb systems for CAPA Review Board, Management Review, CAPAs, and other trending requests. Maintaining existing modules within the Oracle

How will you make an impact? Glaukos is a medical technology and pharmaceutical company that's advancing the treatment of ophthalmic diseases. At Glaukos, we are pioneering new treatments for chronic eye diseases and are focused on novel therapies for the treatment of glaucoma (market leader iStent inject W), corneal disorders and retinal diseases. Glaukos is looking for

How will you make an impact? The Statistical Programmer II generates datasets, tables, listings and graphs to support statistical analyses of data for clinical studies, regulatory submissions and publications. This position requires a basic understanding and ability to provide datasets using current industry standards including Clinical Data Interchange Standards Consorti

Manage and coordinate manufacturing and supply chain activities in support of development, clinical and marketed products. Provide expertise in support of internal qualifications and process validations. Provide expertise in support of qualifications of CRO's, CMO's, CPO's, 3PL's and related vendors in support of product manufacturing and supply chain. Key contributor on

& Work Experience Design Control Working with development teams to assure Clear and concise user requirements, product specifications, plans, verification and validation studies, risk management strategies and other relevant design control deliverables, Test protocols that include qualified and repeatable test methods, appropriate risk based sample sizes and clear test ins