Bhaskar Reddy

Senior Statistical Programmer- Ii @Docs

DE

Coordinated and led statistical programming team/s to successful completion of submission studies within given timelines and budget.• Monitored project resourcing, project budgets, and identified changes in scope.• Ensured quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP and/or other international regulatory requirements. • Maintained all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.• Provided broad support, including advice on new technologies and industry technical standards (e.g. EDC, CDISC, Statistical principles, CFR Part 11, electronic submissions, applications and communications technologies, etc.) and their integration into Programming processes.Assisted in the production and QC of analysis plans, produced and QC’ed TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.• Provided inputs into weekly/monthly forecasts and monitored the completion of forecasted units.• Created standard macros and applications to improve the efficiency of the department.• Consulted with sponsors on technical/regulatory issues.• Represented Statistical Programming on cross-functional technical initiatives.• Contributed to the development and delivery of internal technical trainings.• Mentored and trained other members of the department.