Senior Assurance Manager

degree or foreign equiv. in pharmacy, statistics, or a related field, PLUS 5 yrs. of exp. in a statistical programming position for pharmaceutical or biotech clinical research or development; 3 yrs. of exp. creating SDTM/ADaM datasets while following CDISC standards, creating TLFs, developing independent programs to validate analysis datasets and TLFs generated by vendor while ensuring compliance with CDISC and submission requirements, and developing and maintaining SAS programming macros to support internal data review and monitoring.
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