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Principal Statistical Programmer (FSP)Job ID 80277BR India - Any Region - Home Based
The Principal Statistical Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Principal Statistical Programmer can fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required. Further, the Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.
• Ability to fill Statistical Programming Lead role on projects.
• Input into and negotiate statistical programming timelines.
• Ensure that timelines are adhered to Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
• Monitor project resourcing, project budgets, and identify changes in scope.
• Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. Review statistical analysis plans and mock-shells.
• Review database set-up specifications.
• Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
• Interact with sponsors and internal stakeholders with regard to statistical programming issues.
• Assist project teams in the resolution of problems encountered in Deliver best value and high-quality service.
• Check own work in an ongoing way to ensure first-time quality.
• Use efficient programming techniques to produce/QC derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings.
• Produce/QC dataset specifications and other process supporting documents and submission documentation.
• Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements
• Candidates must have minimum of 8+ years of statistical programming in clinical/pharma domain
• Strong programming and analytical skills using SAS software Good knowledge and understanding of CDISC SDTM, ADaM and Define.xml standards & TLF’s
• Proven knowledge of regulatory guidance documents, Proven understanding of clinical trials, fundamentals of clinical research, GCP.
• Strong communication (verbal and written) & interpersonal skills Good team player, self-disciplined & self-motivated with ability to learn faster
• A Masters in statistics, mathematics, or another relevant discipline. Or B.Sc., Life Science Graduates/ Statistics Graduate/ SAS certified preferable.
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