Statistical Programmer
Statistical Programmer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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.
Employment Type
Full Time
