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| Job Location | Bangalore, Chennai, Hyderabad, Delhi |
| Education | Not Mentioned |
| Salary | Rs 2.0 - 7 Lakh/Yr |
| Industry | Pharma / Biotech |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
The Principal Statistical Programmer will be recognized as a subject matter expert, providing technicalsupport and expert advice to internal and external sponsors, and works independently to support variousprograming activities related to the analysis and reporting of clinical study data. In addition, the PrincipalStatistical 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, thePrincipal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity inrelation to budgets.QualificationsAbility to fill Statistical Programming Lead role on projectso Input into and negotiate statistical programming timelines.Ensure that timelines are adhered to.o Coordinate and lead a statistical programming team tosuccessful completion of a study within given timelines andbudget.o Monitor project resourcing, project budgets, and identifychanges 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, stakeholdermanagement, external sponsor support, resource management,and project management for the required programming taskssupporting clinical trial activities. Interact with sponsors and internal stakeholders with regard tostatistical programming issues. Assist project teams in the resolution of problems encountered inDeliver 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 deriveddatasets (e.g. SDTM, ADaM), tables, figures, and data listings. Produce/QC dataset specifications and other process supportingdocuments and submission documentation. Ensure quality control (QC) is performed on all process andtechnical activities related to derived dataset, table, data listing, andfigure programming in accordance with corporate quality standards,SOPs/Guidelines, ICH-GCP, and/or other international regulatoryrequirements.,
Keyskills :
sassas programmingsdtmdata managementreportingstatistical analysis plansbest valueproject teamsquality controlquality standardsproject managementproject resourcingresource managementresource allocationstatistical analysisstatistical program