Liaise with staff for the development of system enhancements to overcome known problems or further fulfil user requirements Provide key technical consultation with major migration and transition programs Play lead role in complex and sizeable programs and opportunities WHAT YOU SHOULD HAVE 8-11 years of experience in Technical experience in design, development and expert in Systems Development/ Maintenance and/ or technical Integration/ Migration Experience in Management/ Project Management, IT Management, Business Applications, Operating Systems, IT and Comms H/W, Business Analysis/ Process modeling, Statistical Analysis and Reporting, Config Management/ Testing, App Support Business Area Knowledge and analytical skills Attention to detail Conceptual thinking and customer focus Follow up and monitoring Information acquisition Ability to interact with people Organizational awareness Need to work rotate shift, working on public holiday and on-call support on weekend.
Collaborating with other functional groups within the client where necessary to support milestone achievement and to manage study issues and obstacles. Consulting with pharmacogenetics experts on preclinical and medical aspects as well as side effects (including SAEs and SUSARs). Anticipating project risk and implementing mitigation strategies.
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.
WHAT YOU WILL DO Present to or influence customer representatives or vendors and resolve issues Conduct interviews with customers to establish their requirements, presenting concepts and proposals, and providing updates on deliverables Act as a coordinator across projects to prevent delays or misunderstandings Coordinate collaboration with external service providers in terms of assembling own or third-party system components Customize COTS based on pre-determined parameters, and executes customizing tests Document work using the required standards, methods and tools Assist in definition, initiation and design of architecture in projects/ programs Provide expert advice, training and technical assistance to development team, lower level service and support staff May lead others in developing innovative solutions to highly complex problems and contribute to employees’ professional development Act as technical lead of development teams on issues of performance, tools, and standards WHAT YOU SHOULD HAVE 11 years of experience in software engineering with relevant qualifications in IT field and methods including formal methods (e.g.
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!
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.
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