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Senior Statistical Programmer

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Input into and negotiate statistical programming timelines; ensure that timelines are adhered toCoordinate and lead a statistical programming team to successful completion of a study within given timelines and budgetMonitor project resourcing, project budgets, and identify changes in scopeInteract with Sponsors as the key contact with regard to statistical programming issuesProvide technical support and advice to the internal teamCheck own work in an ongoing way to ensure first-time qualityEnsure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performedCoordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g.,,, etc.), tracking spreadsheets, and required documentationAssist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documentsUse efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the departmentProvide input into monthly PERFORM forecasts and monitor the completion of forecasted unitsCreate standard macros and applications to improve the efficiency of the departmentMaintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory complianceBe trained in sponsor WSOPs and disseminate knowledge to project team members as appropriateProactively participate in and/or lead process/quality improvement initiativesWork closely with the Quality Management Groups (QMG) to ensure compliance withWSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as requiredDevelop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenasMaintain and expand local and international regulatory knowledge within the clinical industryAssist project teams in the resolution of problems encountered in the conduct of their daily workProvide relevant training and mentorship to staff and project teams
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 3-5


Bio-Statistician | Bio/Pharma Informatics | Quality Assurance/ Control
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