SR.DATA ANALYST

Lead and mentor EDC programmers in testing electronic data capture technologies including IRT, ePRO, and eCOA; Guide statistical programmers in developing SDTM and ADaM specifications aligned with CDISC submission standards; Facilitate creation of documentation for regulatory submissions such as NDA, BLA, and MAA; Conduct quality reviews and inspection readiness checks of Data Management Trial Master File (TMF) documents; Evaluate EDC systems like Medidata RAVE, InForm, and Oracle Clinical for study-specific needs and present recommendations to clinical teams; Integrate and analyze datasets from pre-clinical, clinical, and natural history sources from a data analysis perspective; Maintain and improve existing data pipelines and data warehouse infrastructure. Skills: SDTM, ADaM, Medidata RAVE, InForm, EDC and Oracle Clinical. Must be willing to travel and/or relocate to work in various locations throughout the US. No Telecommuting.