Master’s or bachelor’s degree in Statistics, Mathematics, Computer Science, or related field
At least 8 years of SAS programming experience in pharmaceutical/CRO settings
Extensive SAS programming experience with SAS macros and CDISC Standards (SDTM/ADaM) and regulatory submission packages
Good understanding of statistical methods, Good Programming Practices, and GCP standards; strong verbal and written communication; ability to travel up to 5%
Requirements:
Provide statistical programming expertise with respect to Statistical Programming and Biostatistics
Develop and validate SDTM/ADaM datasets and tables, listings and figures for assigned projects
Work closely with statisticians to deliver all the statistical deliverables
Create derived data set specifications for all assigned studies and integrated summaries
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.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
