Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet! We look forward to hearing from you. Mein Arbeitgeber The customer is a major organisation undergoing a significant digital transformation within its Information Systems & Digital (TDSI) division.
IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client’s project team to set-up and execute clinical trials.
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. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
As well as contributing to the clinical workload, the successful candidate will have opportunities to be involved in training junior embryologists, service development, research, quality management, donor recruitment and project work. The Deputy Laboratory Manager will support the Laboratory Manager in the delivery of the service and management of the laboratory team.
As well as contributing to the clinical workload, the successful candidate will have opportunities to be involved in training junior embryologists, service development, research, quality management, donor recruitment and project work. The Deputy Laboratory Manager will support the Laboratory Manager in the delivery of the service and management of the laboratory team.
DGF's logistics solutions span the entire supply chain, from the factory to the shop floor. They also include special transport-related services. Our business model is very asset-light, as it is based on the brokerage of transport services between customers and freight carriers.
Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they belong.
Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they belong.
Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they belong.
Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they belong.
Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they belong.