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.
Work with internal teams to ensure effective selection, seamless integration, and strategic alignment of CMOs with organizational goals. Comprehensive End-to-End Product Integration Planning Design and implement a product integration strategy from deal closure to market readiness. Engage early, starting from the due diligence phase, to align with business objectives.
ALPS ALPINE EUROPE GmbH sucht in Unterschleißheim bei München eine/n Working Student Hardware Evaluation & Design (m/f/d) (ID-Nummer: 13653948)
Expertise to handle Agile or Waterfall model-based requirements. Able to design data flow diagram with a flow chart. If have experience on react native that is a plus point to build a mobile application. Dynatrace hands-on experience to do PST test on the application.
Your work is essential to protect DPDHL group’s information assets in a dynamic threat landscape by secure design. To achieve this, you will be interacting with our business colleagues, our solution architects and developers, to name a few. TEAM INTRODUCTION: Information Security Services cooperates with all division under the IT Security, Risk and Compliance Management team to meet business partner's requirements to maintain the confidentiality, integrity and availability of the IT infrastructure and assets.
Comfortable interpreting commercial / financial trends and results, with ability to guide teams to design and execute research and analysis and translate outputs into strategic implications for investorsWell-developed written and verbal communication skills including presentations, chairing meetings / Q&A sessions and report writingKnowledge of key issues and current developments in the biopharma / life sciences industryEvidence of career progression in consulting and/or transaction advisory roles In addition to the skills and experience above, a Manager should have: Bachelor’s degree or equivalent.
Für den Bereich IT-Management suchen wir ab sofort und unbefristet einen: Senior Entwickler (m/w/d) C#/.NET - Azure Functions & Power Platform Voll- oder Teilzeit (35-39 Stunden/Woche) 65.000 - 75.000 Euro Bruttojahresgehalt (abhängig von Ihrer Qualifikation und Erfahrung) Ihre Aufgaben Als Senior C#/.NET Entwickler mit Schwerpunkt auf Azure Functions und Power Platform übernehmen Sie eine zentrale Rolle in der Konzeption, dem Design und der Umsetzung technischer Lösungen für unternehmenskritische Prozesse. Sie sind nicht nur Entwickler, sondern Mitgestalter der Systemlandschaft: Sie entwerfen tragfähige Softwarearchitekturen, erstellen technische Konzepte, sorgen für saubere Dokumentation und arbeiten eng mit Product Ownern, Fachbereichen und IT zusammen.
About us Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. Every day, a team of around 4,800 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare.
Vorbereitung und Erstellung regelmäßiger (monatlicher) Baufortschrittsberichte. Organisation und Protokollierung aller Arten von Projekt-, Design- und Bau-Meetings. Verantwortung für die Projektdokumentation und Übergabe beim Projektabschluss. Du wirst systematisch an mehreren Projekten gleichzeitig unter der Aufsicht eines erfahrenen Projektmanagers und in Zusammenarbeit mit verschiedenen Teammitgliedern - auch aus anderen Geschäftsbereichen - arbeiten.
What you will do Perform high-quality manual testing across multiple client e-commerce projects (Desktop, Mobile Web and Tablet), covering the complete customer journey from discovery to checkout Collaborate closely with frontend developers and project teams to understand client requirements and develop tailored testing strategies for each implementation Oversee quality across diverse client implementations while ensuring consistent excellence and optimal user experiences Take ownership of bug reports and tickets from clients, internal stakeholders, and end-users, prioritizing them based on business impact and project timelines Contribute to the development and evolution of SCAYLE Agency’s testing framework and automated testing strategy across client projects Act as a quality advocate within cross-functional agency teams, promoting best practices and driving continuous improvement across multiple client engagements Coordinate testing efforts across parallel client projects to ensure successful delivery of high-quality features within agency timelines Support holistic testing approaches across the full technology stack, understanding how frontend integrations connect with SCAYLE’s backend systems and third-party services Adapt testing strategies to accommodate varying client requirements, brand guidelines, and technical specifications Who you are You have minimum of 5 years of experience in quality assurance, testing, and debugging of frontend applications, preferably in agency or client-facing environments Proficient in manual testing techniques, including exploratory and destructive testing, as well as automated testing methodologies Familiarity with project management and ticketing tools such as Jira and Confluence for effective collaboration across agency teams and client stakeholders Strong knowledge and experience with testing tools, particularly TestRail, for efficient test management and comprehensive reporting Ability to quickly understand complex, custom-built e-commerce implementations and adapt testing approaches to different client architectures Web technologies: Solid understanding of HTML, CSS, JavaScript, browser developer tools, and REST APIs Experience working with agile methodologies in fast-paced agency environments with multiple concurrent projects Passion for delivering innovative, client-specific features quickly while maintaining the high reliability standards expected by premium brands Detail-oriented approach with strong focus on test case design, business value, brand consistency, and exceptional user experience Excellent communication skills for working directly with high-profile clients and articulating technical issues clearly Nice to have Experience with CI/CD pipelines (e.g., GitLab CI) and integrating automated tests into deployment workflows Knowledge of web performance testing (e.g., Lighthouse, Web Vitals) and optimization for enterprise e-commerce Familiarity with web accessibility (a11y) standards and testing, particularly for compliance-focused clients Previous experience in an agency environment or working on multiple concurrent client projects Understanding of SCAYLE’s modular architecture, Storefront SDKs, and Feature Packages Experience testing headless commerce implementations and API integrations Knowledge of international e-commerce requirements (multi-language, multi-currency, regional regulations) Benefits Hybrid working Fresh fruit every day Sports courses Free access to code.talks Exclusive employee discounts Free drinks Language courses Company parties Help in the relocation process Mobility subsidy State-of-the-art technology Central Location Flexible Working Hours Company pension Professional training Dog-friendly office AY Academy Feedback Culture Job Bikes YOU ARE THE CORE OF SCAYLE.
Your tasks Strategic customer engagement & planning Lead strategic customer dialogues with global decision makers to identify customer's business objectives, supply chain requirements & challenges Create future opportunities by translating customer needs & business trends into potential solutionsLink senior DHL executives with account counterparts at board or senior management level Relationship & opportunity development Position yourself as a strategic resource in a way that senior customer management seeks advice on high impact topicsProactively identify opportunities and develop recommendations on a global & regional level based on financial attractiveness, risk and fit of customer requirements with DHL capabilitiesManage the renewal agenda in a proactive manner at a global and regional level Preparing, winning & implementing the deal Create and present high complexity solutions to customer demonstrating clear business & solution fitEnsure common understanding of service expectations & solutions both with the customer, DHL countries/regions & within CSI Challenge solution delivery team to ensure customer inputs & requirements are translated into DHL offer Service management & account maintenance Act as key contact for customer and channel the communication toaccount teams and DHL internal functionsSupport effective Customer Satisfaction Survey (CSS) process & drive follow up activities to increase customer satisfaction year-on-year Strategic Thinking & Targeting Translate customer strategy into meaningful business opportunities of value for DHL divisions extended to board level independently, and ensure buy-in for the sameProactively identify best fit opportunities for DHL across regions/products/solution Selling & Influencing Develop & articulate business and solution fit that reflects customer’s requirements, sector & product knowledgeDevelop proposals that adhere to internal guidelines & commercial standards Prepare for commercial discussion by identifying customer’s buying criteria & developing strong pricing & negotiation strategies that incorporates knowledge of competitor’s position Developing Commercially Viable & Innovative Solutions Proactively offer x-divisional solutions that leverage all relevant products & capabilities of DHL divisionsEngage customers through consulting studies & customer workshops to identify opportunities to offer innovative solutions, by leveraging a broad network of resources internal and externalUnderstand key DHL & customer’s business drivers (e.g revenue, cost) & anticipate impact of business decisions & solutions based on the macro-economic environment Working Across the Business •Coordinate divisional account team (e.g. monthly team calls) and ensure that necessary resources are available on a global scale •Involve relevant CSI & divisional key stakeholders & secures buy-in & support for CDP, solution offering and implementation Your profile University degree in Business, Logistics or related10-12 years’ experience in Logistics Industry, Service Industry, within the sector or with the Customer 5 years’ experience with one or more DPDHL divisions in regional/ global environment7-10 years’ of commercial management experience5 years’ Consultative Selling experience working at board level in an international environment5 years’ experience in solution design, operational, performance and project managementExcellent analytical & problem solving skillsEffective presentation & facilitation skillsExcellent business English and French (written and oral)Structured work approach International exposure and cultural sensitivityAbility to engage and lead discussions at board level with senior managementAbility to work independently and within a team to deliver resultsAbility to lead and influence without formal authorityAbility to adapt and perform under changing and uncertain conditionsAbility to manage virtual, global teams •Willing to undertake (extensive) international travel Your benefits We offer excellent employee benefits, a competitive salary package and great development opportunities.
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.
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.
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.
Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
As part of our team, you will take on the following responsibilities: You take on strategic responsibility for steering and further developing national and international post‑merger integration programs, aligned with group-wide integration and governance standards.You design and define the Target Operating Model (TOM) and develop sustainable, cross‑company integration strategies to ensure a successful organizational merger.You lead complex, multinational PMI projects and coordinate all involved departments, business units, and functional stakeholders.You implement the integration strategy, derive clear recommendations for action, and ensure target achievement together with the business units and top management.You act as an important sparring partner for internal stakeholders on PMI and transformation topics and advise the executive management on integration risks, synergy potentials, and organizational impacts.You further develop PMI concepts, governance structures, methods, tools, and best practices, and establish them across the group.You build a KPI‑based tracking and reporting framework for the post‑merger integration (PMI) process and align it closely with management.
DKV is the full‑service provider in the field of eMobility, offering tailor‑made solutions for electric vehicles: from charging infrastructure to planning and design, from consultancy to installation and electricity products. As a Customer Support Representative, you are the coordinator and take ownership of our service delivery.
As part of our team, you will take on the following responsibilities: As an Infrastructure Architect (gn), you analyze the existing system and infrastructure landscape and, based on this, develop technical design changes for new software and hardware solutions. You design, plan, and implement infrastructure technology solutions and ensure their sustainable integration into the existing architecture.You are responsible for managing and continuously developing the existing IT services and contribute your expertise in an advisory capacity to other internal IT units.
Your tasks As a Senior Automation Process Analyst (m/f/x) you will be involved in complex 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.
Make an impact: Development of our Customer Relationship Management (CRM) and Supplier Relationship Management (SRM) based on Dynamics 365 OnlineDevelopment of further business applications based on different modular elements of the MS Cloud Stack (Power Apps, Power Automate, Azure etc.)Working with state-of-the-art tools and development methodsCo-determination and design of our development methodology, release processes and agile approachSupport of our development team and management of external developersEffective collaboration with our CRM / SRM team and surrounding projects and product teamsActive design in solution design from the technical requirement to the finished solution What makes you stand out Education: successfully completed education in (business) computer science or a comparable education levelAt least 5 years' experience in the development of .NET, Dynamics, and Azure cloud components (C #, Javascript, DevOps, Visual Studio etc.)
Principal Accountabilities: Collaboration in projects of the European Data Science & Advanced Analytics Team.Concept, design, development and execution of complex innovative AI/Machine Learning solutions as well as execution and implementation of concept studies using advanced statistical methods.Development of deep learning models for structured medical concept extraction from unstructured data.Productionalization of machine learning algorithms in Big Data platforms.Application of modern data mining and machine learning techniques in connection with Healthcare Big Data to identify complex relationships and link heterogeneous data sources.Advanced usage of Large Language Models for summarization, chatbot, entity extraction etc.Develop foundational Deep Learning Models for assets and patients.Builds and trains new production grade algorithms that can learn from complex, high dimensional data to uncover patterns from which machine learning models and applications can be developed.