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As a Strategic Consultant, assist clients to select and manage clinical research organizations (CROs); act as a liaison between clients and CROs; ensure clients’ clinical data analysis needs are met and CROs deliver quality results. Lead a group of consultants and prepare deliverables for regulatory submissions. Independently verify statistical analysis results (QC review) for NDA documents and evaluate vendor deliverables to ensure submission readiness. Establish client departmental processes and document them in SOPS and Work Instructions. Help build client programming teams through developing job descriptions, technically screening candidates, on-boarding and training new hires. Document in-house macros by writing validation plan, user requirements and validation summary report.
As a principal programmer analyst, perform SAS programming activities for FDA submissions including analysis file/ADAM dataset development and customized data displays (summary tables, figures and listings).
Iris Statistical Computing