Review key study documents produced by other functions (protocols, statistical analysis plans [SA - Ps], TFL shells, case report forms) and interact with Statisticians and other clinical team members to ensure programming requirements are understood. Follow SA - Ps, develop specifications and execute derivation algorithms for analysis dataset production. Follow the SDTM and A - Da. M Implementation Guide to develop specifications, create programs to produce CDISC-compliant SDTM and A - Da. M dat... more details
Responsibilities:
Review key study documents produced by other functions (protocols, statistical analysis plans [SAPs], TFL shells, case report forms) and interact with Statisticians and other clinical team members to ensure programming requirements are understood.
Follow SAPs, develop specifications and execute derivation algorithms for
analysis dataset production.
Follow the SDTM and ADaM Implementation Guide to develop specifications, create programs to produce CDISC-compliant SDTM and ADaM datasets and define.xml files.
Generate tables, figures, and listings, (TFLs) in accordance with the SAP and TFL shells to support analyses using Base SAS, SAS Macro, SAS/STAT,
SAS/GRAPH, or other statistical graphics technology.
Create and maintain integrated analysis datasets including closed and ongoing studies.
Validate SAS programs, macros, datasets, and TFL output generated by other Programmers.
Develop or assist in the development of departmental processes and procedures.
Experience and Education:
Experience working in Pharmaceutical/ Biotechnology/CRO industry as a
Statistical Programmer is required (>= 3 years with MS degree; >=5 years with BS degree).
High proficiency in SAS programming and Macro development
Experience working with CDISC SDTM and ADaM compliant data sets
Experience with regulatory submissions and creating Define.XML.
Knowledge of statistics and the drug development process
In-depth knowledge of FDA/ICH guidelines and industry/technology standard practices
Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
Capable of critical thinking and independently identifying issues in existing programs
Solid verbal and written communication skills
Bachelor's /Master's Degree in Statistics, Mathematics, Computer Science, or other related discipline is required; Master's degree is preferred
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