Knowledge of ME Methods & Tools: Methods: WPR, industrial process design, industrialization, Jigs & Tools (J&T), time studies and calculation (e.g. PERT, MTM-STV Airbus). Tools & Systems: SAP (PP/PM), PLM systems (Zamiz, TiCon, TAKSY, DocMaster/ECM), Delmia/Apriso, Google Workspace, Microsoft Office.
Knowledge of ME Methods & Tools: Methods: WPR, industrial process design, industrialization, Jigs & Tools (J&T), time studies and calculation (e.g. PERT, MTM-STV Airbus). Tools & Systems: SAP (PP/PM), PLM systems (Zamiz, TiCon, TAKSY, DocMaster/ECM), Delmia/Apriso, Google Workspace, Microsoft Office.
Furthermore, you will be accountable for standard and best practice setting, knowledge sharing and be involved in special projects (i.e. technology exploration). Automation projects comprise of developing a process design in close collaboration with process experts and automation designers, supporting the automation designer during the technical implementation as well as supporting change management activities within the business function before and after go-live.
We bring together sector expertise, global scale and local knowledge to design and manage supply chains from raw materials and manufacturing through to the delivery of finished goods and return services. And by seamlessly connecting local operations across the world we are able to deliver the future of global trade.
Review civil-related contract elements and prepare quotations for civil design and works. Act as the expert interface between Hitachi, clients, and contractors. Manage external civil design partners and handle internal design tasks.
Review civil-related contract elements and prepare quotations for civil design and works. Act as the expert interface between Hitachi, clients, and contractors. Manage external civil design partners and handle internal design tasks.
We bring together sector expertise, global scale and local knowledge to design and manage supply chains from raw materials and manufacturing through to the delivery of finished goods and return services. And by seamlessly connecting local operations across the world we are able to deliver the future of global trade.
We are seeking for a talented Enterprise Architect – Tools and Monitoring to join our team. You are expected to deliver technical and architecture design and formulate standards related IT monitoring landscape (Infrastructure, Application and Business Process). You will act as the SME (Subject Matter Expert) and 3rd level support and also provide technical consultancy to support the design and implementation planning of new infrastructure technologies.
Experience in set-up and conduct of Phase II clinical trials including in depth knowledge of early phase study designs, protocol writing and clinical pharmacology. Additional experience in conduct of Phase I and Phase III trials would be an advantage.
Key Responsibilities: Leadership: Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or NDA sections Leading studies at an operational level Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures Consult on operational/statistical/therapeutic area topics Knowledge Sharing: Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses Performs as subject matter expert (SME) Risk Management: Identifies risks to project delivery and/or quality, leads in a way to minimize risks Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions Lock and Unblinding Process: Leads the database lock and unblinding process for the statistical team Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules) Statistical Expertise: Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports) Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data) Provide expert review of ADaM reviewers guide (ADRG) and metadata Perform senior biostatistical review (SBR) Produce or perform quality control review of sample size calculations for complex studies Requirements: Masters or PhD degree in Biostatistics or a related field with relevant experience within the life-science industry Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials Expert in strategically collaborating with clinical and drug development expertsExperience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Strong working knowledge of SAS or RExcellent knowledge of CDISC Data Standards Superb communication and collaboration skills Independent and pro-active problem solving skills IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Who you are Expert PHP (Laravel): Deep track record in designing and building complex e-commerce middleware. Architectural Design: Proven ability to document and implement scalable integration patterns for enterprise systems (ERP, PIM, PSP). AWS & Infrastructure: Expertise in core services (EC2, ECS/EKS, SQS, Kafka) and Infrastructure as Code (Terraform).
In addition to the responsibilities listed above, the Therapeutic Strategy VP will be expected to: Lead and support clinical trial design and all associated aspects for various clients. Provide strategic and therapeutic area guidance for clinical development plans in compliance with applicable regulatory, medical, and ethics guidelines.
We are seeking for a talented Enterprise Architect – Tools and Monitoring to join our team. You are expected to deliver technical and architecture design and formulate standards related IT monitoring landscape (Infrastructure, Application and Business Process). You will act as the SME (Subject Matter Expert) and 3rd level support and also provide technical consultancy to support the design and implementation planning of new infrastructure technologies.
Mein Arbeitgeber Fire Point Rocket Technology (FPRT) is a defense technology company operating at the intersection of advanced chemistry and modern rocket propulsion. We design and manufacture solid rocket fuel and propulsion components that power next-generation defense systems, with uncompromising focus on safety, quality, and compliance.
Mein Arbeitgeber Fire Point Rocket Technology (FPRT) is a defense technology company operating at the intersection of advanced chemistry and modern rocket propulsion. We design and manufacture solid rocket fuel and propulsion components that power next-generation defense systems, with uncompromising focus on safety, quality, and compliance.
Your tasks As an Automation Process Analyst (m/f/x) you will be involved in automation projects for at least one of the GBS business functions (e.g. Finance, HR, etc.). This entails developing a process design in close collaboration with process experts and automation designers, supporting the automation designer during the technical implementation phase, as well as supporting change management activities within the business function before and after go-live.
Company description 💧 Aliaxis is a leading technology company that designs sustainable, easy to install, and innovative fluid management solutions. Over 15,000 people have selected to work for us in more than 40 countries, meeting our customers’ most demanding needs for pipes and fitting systems in building, infrastructure, industrial and agriculture sectors.