Job Description

• Demonstrated practical understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry.
• Demonstrated satisfactory ability to apply SAS programming knowledge and work independently to solve problems related to non-routine situations.
• Responsible for the creation and validation of SDTM, ADaM and TLFs for CSR, ISS, and Client following SOPs, department, and project standards.
• Ensure internal consistency of output and assess consistency with other activities for the project (e.g., ISS, Client), as applicable.
• Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and resolving Pinnacle21 checks.
• Responsible for the creation and accuracy of derivations as defined in the protocol and statistical analysis plan.
• Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
• Ensure consistency across studies within a project.
• Responsible for the creationof data definition documents, TOCs, and support submission related activities.
• Learn and maintain expertisein the use of the utilities and macros developed for the Statistical Programmers.
• Develop new macros and utilities.
• Provide accurateand timely responses to requests from clients with a sense of urgency.
• Be compliant with training requirements.

• MS in Statistics, Computer Science, or a related field with 3+ years of SAS programming experience in Pharmaceutical or related industry OR BS
• Statistics, Computer Science, or a related field with 5+ years of SAS programming experience in Pharmaceutical or related industry.
• E-sub experiences (CDISC dataset, creating define file, etc.)
• Strong experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
• Strong working experience/skill in SDTM and ADaM datasets creation/validation.
• Strong technical and communication skills, both oral and written.
• Competent in SAS programming, macro, and utilities development.

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