Statistical Analyst II

Responsibilities: 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.