Job Summary :
The role of Statistical Programmer is to perform statistical programming activities for all assigned clinical studies sponsored by company.
Key Responsibilities
Provide statistical programming expertise with respect to Statistical Programming, Biostatistics.
Perform / Coordinate all statistical programming related tasks.
Develop and Validate SDTM / ADaM datasets and tables, listings and figures for assigned projects.
Works closely with statisticians to deliver all the statistical deliverables.
Create derived data set specifications for all assigned studies and integrated summaries.
Provide oversight and guidance for all statistical programming related activities.
Review statistical analysis plans for all assigned studies and integrated summaries and develop / assist in generating mock tables.
Review annotated case report forms and provides comments.
Contribute to process improvement initiatives as assigned.
Qualifications, Experience & Competencies
Education / Training : Master s or bachelor s degree in Statistics, Mathematics, Computer Science, or any related field.
At least 8 years of SAS Programming experience including statistical programming experience in pharmaceutical / CRO setting.
Extensive experience in applying SAS programming language, preferably in pharmaceuticals setting. Knowledge in SAS macros.
Very good knowledge of CDISC Standards, including SDTM, ADaM and regulatory submission packages
Good understanding in statistical methods used in statistical analysis.
Good understanding in Good Programming Practices in pharmaceutical industry.
Good verbal and written skills
Fundamental knowledge of GCP standards
Ability to travel up to 5% based on the needs of the business.
Statistical Programmer • Miami, FL, US
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