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.
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.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
WHAT YOU WILL DO Interactions primarily involve presenting to or influencing business representatives or vendorsInteract primarily in issues related to specific phases of work or technical issuesParticipate in project meetingsSpecify logical and physical test cases, starting scenarios and test scriptsSet up and maintain test environmentsExecute manual and automated test cases (dynamic testing)Check and assess test resultsManage defectsProvide expert advice, training and technical assistanceContribute to employees’ professional development WHAT YOU SHOULD HAVE: If you are highly motivated, creative and desire to start and develop your IT career in a fast-paced environment, you have come to the right place!
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.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
We are looking for an exceptional Board-Certified physician to join our team as a Medical Strategy Lead to help us expand our CAGT portfolio, with an emphasis on Gene Therapy/Gene Editing platforms, and advance this dynamic and rapidly expanding area of clinical development.The CAGT Medical Strategy Lead is a subject matter expert with experience in clinical research and clinical trials in CAGT and especially in the areas of Gene Therapy/Gene Editing, who will be a champion for CAGT across IQVIA.The key remit of the role is drive growth of the IQVIA CAGT portfolio through scientific and clinical expertise.
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience.
The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in Cardiovascular 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.
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.
Expert Internal Audit IT (gn) fulltime/ parttime (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.