namrata parab

Program, plan and co-ordinate the programming, testing, and documentation of statistical programs for use in creating statistical tables, listings, figures, analysis datasets (ADaM) and SDTMs as per CDISC standards for therapeutic areas like Oncology and Bone. Develop specifications for SDTMs and ADaMs as per CDISC standards Act as a back-up lead and point of contact for the study team. Train new joiners on metadata reporting, quality control and actively provide consulting, training and support for programmers as necessary Work closely with Statisticians, Data Managers and CDISC Consultants to ensure work is completed to the required standards.

Handling critical assignments, perform Analysis and Reporting and all other Programming related activities for FDA submission studies and ISS studies i.e. Integrated Summary of Safety for various therapeutic areas for a global client like Pfizer and Merck using SAS. Work towards team’s productivity, work allocation, utilization and ensure that timelines for deliverables across all projects are met and that they comply with established performance standards. Identifying training needs of team members and driving training plans to ensure the improvement areas are addressed and efficiencies are increased. Managing the recruitment process to hire SAS Programmers; single handedly.

Program, plan and co-ordinate the programming, testing, and documentation of statistical programs for use in creating statistical tables, listings, figures and analysis datasets in CDISC standards for global pharmaceutical clients like Merck and Novartis. Perform, coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. Manage project budget and resource requirements, understand the scope of work, budget and quote assumptions, estimate the work completed, manage out of scope and provide revenue and resource forecasts Proactively nominated myself to implement a complex Statistical procedure – Multiple Imputations within a series of studies with tight timelines. Helped other project teams to streamline this procedure. Mentor and provide training and guidance to project team and staff.