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.
Hays masters the entire IT job spectrum, from support to software architecture or digitalisation – thanks to our broad portfolio, we have something for everyone. In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations.
HR-Manager (m/w/d) Experten. Talente. Persönlichkeiten Einfach exzellente Aussichten! Wir sind eine Marke der I. K. Hofmann GmbH und bieten die besten Jobs für Fach- und Führungskräfte bei renommierten Unternehmen.
Cloud Workload Protection Platforms, Cloud Security Access Brokers, etc) and deployment • Design and implementation of a secure hybrid IT environment that integrates different cloud services with our data center hosted services in a global environment • Collaborate with developers, owning the "Sec" part in "DevSecOps" to ensure that cloud-native workloads are deployed securely • Perform regular/continuous security posture evaluations and own the continuous security improvement program for existing deployments - Communicate regularly to our stakeholders about risk position and mitigation • Be point of contact for business and IT stakeholders by means of close collaboration to ensure secure design and transition into new target state • Support and train members of the security team on new cloud technologies • Be subject matter expert for multi cloud environment WHAT YOU SHOULD HAVE: • You are a cloud subject matter expert with more than 5 years of experience in engineering and / or securing cloud technologies and deployments (IaaS, PaaS, SaaS), preferably Google Cloud, Amazon or Microsoft Azure • Cloud Security Posture Management and Cloud Workload Protection Platforms are familiar to you
Your Responsibilities: Support the resolution of complex quality issues and continuous improvement projects by defining measurement standards and identifying/facilitating improvements to increase: Process performance and product adherence to standards Reliability of dedicated processes Repeatability of processes during the initial design phase, prior to any process changes, and continuously throughout the product lifecycle Support Quality focal points for new development projects Support APQP deployment within the Quality scope Facilitate PFMEA (Process Failure Mode and Effects Analysis) Support the development of quality solutions/technologies within new development initiatives together with subject‑matter experts Support quality stream meetings and coordinate activities between sites and organizations Process Quality Management: Ensure consistent application of process management guidelines in line with the EN9100 standard Ensure the process referential (competences, resource models, documentation plan, process networks, deployment areas) is up to date, managed, and continuously improved Proactively support the Process Management Teams in managing the process referential and improving process maturity Ensure that any process change is properly addressed by checking the consistency of the changes and their impacts Collaborate with local and central Process Management Teams to improve Airbus Business Process Management Ensure implementation and effectiveness of process adherence by monitoring progress and collecting adherence results Ensure the quality of process deliverables and surveillance plans, and review process resources, performance indicators, compliance results, etc.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
Zu deinen Aufgaben zählen Du betreust die User aus unseren Fachbereichen bei auftretenden Fragen im täglichen Umgang mit der eingesetzten Software In deiner Funktion als Key User verantwortest du die Stammdatenwartung und das Customizing der Systeme Du testest die Funktionalität der Software sowohl im laufenden Betrieb als auch nach Updates und Prozessanpassungen Du führst Schulungen für neue und bestehende User durch und sorgst dadurch für einen optimalen Einsatz der Programme Du unterstützt die Niederlassungen bei Anwendungsproblemen, erkennst Optimierungspotentiale und übersetzt diese Anforderungen gemeinsam mit deinem Team und dem Softwarepartner in konkrete Lösungsansätze Du begleitest unsere IT-Projekte, die Analyse unserer Applikationslandschaft sowie die Einführung neuer Software aktiv mit Am besten passt du zu uns, wenn du folgendes Profil mitbringst Wichtiger als dein bisheriger Werdegang ist für uns deine persönliche Einstellung Du interessierst dich dafür, was Software leisten kann - am liebsten verwendest du das Zahnrad-Icon Du zeichnest dich durch Flexibilität und Leistungsbereitschaft aus und lernst gerne neue Systeme und Anwendungen kennen Bei Projekten und Softwareausrollungen in Österreich sowie in angrenzenden Ländern zählen wir auf deine Reisebereitschaft Du bist lösungsorientiert, unterstützt unsere User aktiv und stellst so einen reibungslosen Betrieb sicher Wir bieten dir folgende Benefits Ein erfahrener Experte begleitet dich während deiner gesamten Einschulungszeit und darüber hinaus Ein breitgefächertes Aufgabengebiet mit vielen Gestaltungsmöglichkeiten und Raum für Selbstständigkeit Ein krisensicheres, breit aufgestelltes Familienunternehmen mit schnellen Entscheidungswegen Eine Dauerstelle - wir freuen uns auf eine langfristige Zusammenarbeit mit dir Und vieles mehr Weiterentwicklung Wir unterstützen berufliche und persönliche Weiterentwicklung, bieten hohen Gestaltungsspielraum und forcieren interne Karrieren.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
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.
Arvato SE – Consumer Products sucht in eine/n Senior Expert Business Process Manager (m/w/x) (ID-Nummer: 13689095)
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
As part of the ABOUT YOU Group, SCAYLE unites a diverse team of experts from over 82 countries working in Hamburg, Berlin, and remotely across Europe. Global brands such as Manchester United, Deichmann, Fielmann, s.Oliver, FC Bayern, and Marc O’Polo trust SCAYLE to innovate and grow their businesses.
In dieser neuen Rolle führen Sie eigenständig alle Aktivitäten, bestehend aus Bewertung, Planung, konzeptioneller Umsetzung und Implementierung sowie Überprüfung, Wartung und Stilllegung von studienspezifischen IRT-Konzepten.Sie agieren selbstständig als IRT-Vertreter*in in bereichsübergreifenden und funktionsübergreifenden Studien- und Projektteams und besitzen fundierte Expertise in der technischen Umsetzung von IRT-Konzepten und klinischem Studiendesign im Hinblick auf Compliance und Arzneimittelsicherheit.Sie tragen auch zur kontinuierlichen Weiterentwicklung von IRT-Konzepten bei, indem Sie neue Ansätze und Lösungen einbringen, um die Systeme auf dem neuesten Stand zu halten.Sie stellen sicher, dass alle Arbeiten unter Berücksichtigung der Patientensicherheit und in Übereinstimmung mit GMP und GCP sowie US-, EU- und anderen internationalen Richtlinien durchgeführt werden. Zusätzliche Aufgaben für die Expert-Rolle:Sie unterstützen bei den Aktivitäten zur Validierung von computergestützten Systemen. DAS BRINGEN SIE MIT: Anforderungen IRT Specialist: Masterabschluss in Naturwissenschaften und mehrere Jahre Erfahrung in einer verwandten wissenschaftlichen Disziplin oder Bachelorabschluss mit langjähriger Erfahrung in einem verwandten Bereich oder Erfahrung im Qualitätsumfeld.Erfahrung im IRT-Bereich, nachgewiesenes vertieftes Wissen über die technischen Aspekte und Funktionen eines IRT-Systems (von Vorteil).Gute Kenntnisse des generischen Software-Entwicklungszyklus, einschließlich der Validierung von Cloud-Systemen (von Vorteil).Gute Kenntnisse der regulatorischen Anforderungen und GMP/GCP-Vorgaben in der Pharmaindustrie und deren Anwendung auf die Funktion sind erforderlich.Gute Kenntnisse globaler investigativer Arzneimittelaktivitäten sowie allgemeiner klinischer Studienausführung und -design.Fähigkeit, komplexe Aufgaben eigenständig zu initiieren und zu analysieren, unter Berücksichtigung der geltenden Vorschriften, Wirtschaftlichkeit und Zeitpläne.Ausgezeichnete Kommunikationsfähigkeiten und fließend in Englisch, sowohl in Wort als auch in Schrift.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
This is achieved through tailored training programs and relevant projects that enable career progression, for example, from a project team member to a project manager. Additionally, we offer internal training programs and expert lectures conducted by our project team members, covering topics relevant to quality managers, project managers, design engineers, FEM analysts, test engineers, programmers, and automation specialists. uberi zirnij schrift
Exceptional problem-solving and algorithmic thinking skills, coupled with a deep understanding of software design patterns and clean code principles. Expert-level knowledge and practical experience in building modern, scalable web applications using React, TypeScript, and advanced CSS/Styling techniques.
Exceptional problem-solving and algorithmic thinking skills, coupled with a deep understanding of software design patterns and clean code principles. Expert-level knowledge and practical experience in building modern, scalable web applications using React, TypeScript, and advanced CSS/Styling techniques.
JOIN OUR TEAM IN COLOGNE FOR A FULL-TIME POSITION, STARTING AS SOON AS POSSIBLE. Expert “Automation Process Analyst (m/f/x)” in the Center of Digitization DO YOU HAVE PLENTY OF KNOWLEDGE AND WANT TO MAKE A DIFFERENCE?
You can therefore expect to: Identify user needs, design inputs and specifications through participation in the project start-up phase where interaction with key opinion leaders, doctors and other experts worldwide is crucial to fulfil the ambitious innovation targets Be a key influencer in significant development projects within Ambu, either through a mechanical design or lead role Develop new, and further improve existing, mechanical design solutions of components and assemblies as well as optimization of existing designs for Ambu's extensive product portfolio within endoscopy, anesthesiology, and patient monitoring Have the responsibility for the mechanical design and construction of functionalities, parts and assemblies including quality aspects for robust and safe medical products Translate technology concepts into fully working prototypes ready for feasibility testing and process evaluation including documentation Ensure that the component or product is manufacturable in high volume, fulfils function and stays within defined cost framework Ensure continually updated documentation in accordance with the regulations from FDA and ISO certification including FMEA's, risk assessments and tolerance analyses Trust cooperation with internal and external partners.
The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in CNS clinical development. As a subject matter expert, the Medical Strategy Lead will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.
You have initial experience in the functional and disciplinary leadership of a team.You demonstrate strong analytical skills, particularly in profitability analyses, general evaluations, and variance analyses.You take responsibility for international initiatives and projects, for example to optimize planning and reporting processes.You act as a strong communicator and trusted advisor as well as a central interface for executive management, the executive board, and other internal and external stakeholders.You have very strong technical expertise, especially advanced Excel skills at expert level, experience in building BI dashboards, and HR KPI management.You communicate fluently and confidently in both English and German.You have solid knowledge of SAP FI/CO, including BW.
Ein professionelles Umfeld mit hohem fachlichem Niveau, ein wertschätzendes Miteinander und ein echtes Verständnis für IT-Sicherheit als Teamleistung. Bei indevis arbeiten Expert*innen unter Expert*innen – technologiebegeistert, lösungsorientiert und immer mit dem Blick aufs große Ganze. Werde Teil der indevis Guardians – und gestalte mit uns Cybersicherheit der Zukunft!
Supplier Quality Engineer Packaging (m/w/d) Experts. Talents. Personalities. Ensure packaging quality and drive global pharmaceutical standards! For our esteemed client in the pharmaceutical industry, we are looking for a Supplier Quality Engineer Packaging (m/f/d) based in Bad Homburg.
Senior Expert PMI (gn) Vollzeit/ Teilzeit (hybrid) Your job at DKV Mobility? As part of a leading European B2B platform for on-the-road payment solutions, you will work in an exciting environment.
JOIN OUR TEAM IN COLOGNE FOR A FULL-TIME POSITION, STARTING AS SOON AS POSSIBLE. Senior Expert “Automation Process Analyst (m/f/x)” in the Center of Digitization DO YOU HAVE PLENTY OF KNOWLEDGE AND WANT TO MAKE A DIFFERENCE?
Das Team Data Science & Advanced Analytics – mit Standorten in Frankfurt, Philadelphia, Mailand, Madrid, Athen, Warschau und Peking sowie einem Netzwerk von mehr als 300 Experten weltweit – ist das globale Kompetenzzentrum für Statistik und Data Science bei IQVIA. Das Team ist verantwortlich für die Entwicklung statistischer Verfahren und Methoden, die in Qualitätssicherungsprozessen, Datenimputationen, Datenprojektionen, Forecasting und vielen weiteren Bereichen für Healthcare‑Paneldaten eingesetzt werden, darunter Apothekenumsätze, E‑Commerce‑Daten, Krankenhausverbrauch, verschreibende Ärzte sowie longitudinale anonymisierte Patientendaten.