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
Very good knowledge of CDISC Standards, including SDTM, ADaM and regulatory submission packages
Requirements:
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
Work closely with statisticians to deliver all the statistical deliverables
Job description
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.
