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 ADaM, TLFs for CSR, ISS, and Client following's SOPs, department, and project standards.
• Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and resolving Pinnacle 21 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 creation of data definition documents, TOCs, and support submission related activities.
• Learn and maintain expertise in the use of the utilities and macros developed for the Statistical Programmers.
• Develop new macros and utilities.

Requirements:

• MS in Statistics, Computer Science or a related field with 5 to 7 years of SAS programming experience in Pharmaceutical or related industry OR.
• BS in Statistics, Computer Science or a related field with 5 to 7 years of SAS programming experience in Pharmaceutical or related industry.
• Strong experience with clinical trials, including familiarity with expectations of regulatory agencies,
• Strong working experience/skill in ADaM datasets creation/validation.
• Strong technical and communication skills, both oral and written.
• Competent in SAS programming, macro, and utilities development.
• Good CDSIC knowledge.
• Provide accurate and timely responses to requests from clients with a sense of urgency.
• Be compliant with training requirements.

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