WOCHENSTUNDEN: 40 Stunden ARBEITSZEIT: Vollzeit Was Dich erwartet: Ein sicherer Arbeitsplatz in einem internationalen Unternehmen Angenehmes Arbeitsklima mit kurzen Entscheidungswegen Kontinuierliche Schulungs- und Weiterbildungsmaßnahmen AUSGESCHRIEBEN SEIT: 13.01.2026 DEIN TOURGUIDE .fusion-slider-61 .flex-direction-nav a{width:63px;height:63px;line-height:63px;font-size:25px} Loading...
WOCHENSTUNDEN: 40 Stunden ARBEITSZEIT: Vollzeit Was Dich erwartet: Ein sicherer Arbeitsplatz in einem internationalen Unternehmen Angenehmes Arbeitsklima mit kurzen Entscheidungswegen Kontinuierliche Schulungs- und Weiterbildungsmaßnahmen AUSGESCHRIEBEN SEIT: 13.01.2026 DEIN TOURGUIDE .fusion-slider-61 .flex-direction-nav a{width:63px;height:63px;line-height:63px;font-size:25px} Loading...
Deine Berg Begleiter Unser Auftraggeber ist ein renommiertes international tätiges Unternehmen mit Sitz in Nürnberg. Wir begleiten Dich im gesamten Bewerbungsprozess und informieren Dich detailliert über unseren Auftraggeber: 100% persönlich, professionell und vertrauensvoll.
Deine Berg Begleiter Unser Auftraggeber ist ein renommiertes international tätiges Unternehmen mit Sitz in Nürnberg. Wir begleiten Dich im gesamten Bewerbungsprozess und informieren Dich detailliert über unseren Auftraggeber: 100% persönlich, professionell und vertrauensvoll.
WOCHENSTUNDEN: 39 Stunden ARBEITSZEIT: Vollzeit Was Dich erwartet: Ein sicherer Arbeitsplatz in einem internationalen Unternehmen Angenehmes Arbeitsklima mit kurzen Entscheidungswegen Zentrale Lage mit guter Verkehrsanbindung AUSGESCHRIEBEN SEIT: 13.01.2026 DEIN TOURGUIDE .fusion-slider-61 .flex-direction-nav a{width:63px;height:63px;line-height:63px;font-size:25px} Loading...
Du verfügst über fundierte Kenntnisse in der Zollabwicklung und in internationalen Versandprozessen. Du arbeitest strukturiert, präzise und verantwortungsbewusst. Du bist kommunikationsstark und qualitätsorientiert.
Deine BERG Begleiter Unser Auftraggeber ist ein international agierendes Unternehmen aus der Automatisierungstechnik mit Sitz in Fürth. Das technologiegetriebene Unternehmen entwickelt hochpräzise Antriebslösungen für industrielle Anwendungen und legt besonderen Wert auf Qualität, Verlässlichkeit und Effizienz – auch in den kaufmännischen Abläufen.
Du koordinierst den komplexen Terminkalender der Führungskraft, planst internationale Reisen und organisierst interne wie externe Meetings. Du erstellst eigenständig Präsentationen und Berichte – auch auf Basis umfangreicher Excel-Dateien – und lieferst inhaltliche Inputs.
A degree from an accredited and internationally recognized school is required2+ years clinical research relevant experience, including hands on operational delivery and/or drug development experienceRobust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in CardiovascularExcellent skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; e.g. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesDemonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall offeringStrong clinical research skills and commitment to evidence-based and patient-centered clinical development Professional Skills Excellent communication, presentation and interpersonal skills, including good command of English language (both written and spoken)Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organizationInnovative and strategic thinkerStrong business acumen including confidence with financial considerations, excellent negotiation and influencing skills, and comfort working in both sales and operational environmentsFlexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when requiredConfident and capable in the use of technology, applications and other media e.g. databases and internet to research assess new opportunities, maintain currency of therapeutic and operational knowledge and competitive landscape.Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results Interpersonal Skills Ability to establish and maintain effective working relationships with co-workers, managers and clients.
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; e.g. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall offering Strong clinical research skills and commitment to evidence-based and patient-centered clinical development Professional Skills Excellent communication, presentation and interpersonal skills, including good command of English language (both written and spoken) Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organization Innovative and strategic thinker Strong business acumen including confidence with financial considerations, excellent negotiation and influencing skills, and comfort working in both sales and operational environments Flexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when required Confident and capable in the use of technology, applications and other media e.g. databases and internet to research assess new opportunities, maintain currency of therapeutic and operational knowledge and competitive landscape.
·Strong global knowledge and awareness/understanding of the biopharma industry, drug development lifecycle and operational clinical trial delivery.In-depth knowledge of applicable clinical research regulatory requirements; e.g. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Strong business acumen including confidence with financial considerations, excellent negotiation and influencing skills, and comfort working in both sales and operational environments.Strong customer management skills and demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall program/portfolio.Strong leadership skills, ability to lead a virtual team in a matrix organization.Ability to work strategically to realize organizational and project goals, identifying and developing positive and compelling visions for the successful delivery of projects and taking account of a wide range of issues across, and related to, the projects and the organization.Strong presentation skills.Excellent written, verbal communication and interpersonal skills, including good command of English language (both written and spoken).Strong software and computer skills, including MS Office applications.Must have prior experience in the Clinical Research Organization (CRO) industry MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences and relevant global clinical research experience (director level), including hands on operational delivery and/or drug development experience in the applicable therapeutic area (Internal Medicine/Immunology) At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world.
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.