Dipa V.
Sr Manager Programming @ThermoFisher Scientific
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WORK HISTORY
Sr Manager Programming @ThermoFisher Scientific
Provided senior-level leadership for global Oncology clinical trials with integrity to ICH-GCP, CDISC standards (SDTM/ADaM), and regulatory compliance; delivered quality safety datasets and FDA submissions earlier and at lower expense.• Designed and implemented the \"Employee of the Quarter – Reorganization Program\" in the Biostatistics and Statistical Programming groups, formally recognizing 15 outstanding performers and a culture of excellence.• Supported Biostatistics infrastructure by streamlining internal communication procedures, standardizing documentation, and disseminating critical corporate information to ensure functional teams\' alignment.• Worked with Clinical Operations, Data Management, and outside CROs by function on project planning, resource management, timeline management, and budget tracking; ensured data integrity by allowing on-time database locking and clean patient data collection.• Led and guided a team of 15 Statistical Programmers and Biostatisticians, driving operational efficiencies through the implementation of agile practices, technical skill development, and performance metrics; improved FTE utilization and retention rates for two years.• Executed thorough QC/validation of SDTM and ADaM datasets, TLF outputs, SAPs, and CRF annotations; managed end-to-end deliverables in accordance with regulatory requirements and reported out-of-scope deviations to ensure compliance of the project.• Developed comprehensive programming specifications for ADaM and SDTM datasets, reducing rework and downstream clarifications by 40%; facilitated seamless integration into statistical analysis workflows.
EDUCATION
Sardar Patel University
B.S
The Maharaja Sayajirao University of Baroda
Master Degree
Loyola University of Chicago
Master Degree
ABOUT DIPA V.
Ex Thermo Fisher Scientific, Labcorp | CDISC Standards, GCP
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