Mortgage Underwriter(Dallas,TX or Henderson, NV)Responsibilities:
- Demonstrated practical understanding of SDTM data sets creation and SAS programming concepts and techniques appropriate to the pharmaceutical industry.
- Demonstrated satisfactory ability to apply SAS programming knowledge to solve problems related to non-routine situations.
- Ensure internal consistency of output and assess consistency with other activities for the project, as applicable.
- Follow all department and project standards.
- Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and running all checking utilities.
- Responsible for ensuring peer review has been completed for all activities for the assigned projects.
- Ensure clarity, accuracy and consistency of case report forms (CRFs), database definitions, and specifications for analysis data sets for individual studies.
- Review for consistency across studies within a project.
- Ensure accuracy of database quality assurance checks and assess data accuracy and consistency.
- Develop database checks for routine and with supervision develop checks for non-routine situations.
- Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
- Responsible for the creation and accuracy of derivation programs for routine and with supervision create derivation programs for non-routine situations.
- Responsible for ensuring peer review has been completed for all derivation programs for assigned projects.
- Responsible for the creation and accuracy of submission data sets and analysis programs for routine situations and with supervision for non-routine situations.
- Responsible for the creation of data definition documents and TOCs.
- Responsible for ensuring peer review for all submission data sets and programs for the assigned projects.
- MS in Statistics, Computer Science or a related field with 5+ years of experience in efficacy programming.
- High degree of technical competence and communication ability, both oral and written.
- Competent in SAS programming and Macro development.
Pharmaceutical or related industry experience with clinical trials,including familiarity with expectations of regulatory agencies, especially FDAand EMEA.