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Senior Programmer - SR COAR SAS

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

.Responsible for the integrity of the programming/computing solutions for a relatively small project or indication.2.Is the scientific lead for programming expertise liaising with Biometrician and statistical scientific counterparts within the teamfor a relatively small project or indication 3.Leads the full execution of final production output generation (tables, listings and graphics) for clinical trials. Responsible for programming activities for a relatively small project or an indication.4.In conjunction with the Biometrician/Statistical Scientist, develop study-level programming standards and ensure compliance with project-level/company standards. As required, provides support to development of project-level programming standards for a relatively small project/indication, following internal guidelines. 5.Make certain that documents and specifications are consistent and comply with company standards by providing input into eCRF and data structures, tables, listings and figures for Phase I-IV clinical trials and submission activities.6.Program (according to specifications) analysis datasets, pooled datasets, listings, tables, and figures for Phase I-IV clinical trials and for SCS and SCE with high quality and within milestones. Prepare Case Report Tabulations for the submission as required. 7.In consultation with the Biometrician/Statistical Scientist, responsible for development of programming specifications of analysis datasets and pooled datasets.8.Maintain QC compliance and responsible for trial records including archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality deliverables. 9.Review planning of edit checks; assist non-standard, complex data validation programming as needed according to agreed plans for the clinical trial.10.Assume the role of subject matter expert / trial domain expert to ensure seamless outsourcing, according to the agreed contract and internal business guidance. 11.Provide support to process improvement initiatives and participate in non-clinical project activities as required.12.Support/conduct training sessions to programmers on programming standards and Novartis processes/SOPs as required 13.Contribute to non-clinical initiatives as required14.Provide programming expertise in developing/selecting/modifying basic/intermediate MACROs for reporting standards.
Degree: ME/ M.Tech./ MS (Engg/ Sciences)

Additional Degree: BE/ B.Tech (Engineering)

Experience: 7-12


Drug Regulation | Environment | Quality Assurance/ Control
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