Senior Statistical Programmer, based in San Clemente, CA will be responsible for generating tables, listings and graphs to support statistical analyses of data for clinical studies, regulatory submissions and publications. This position requires a good understanding and ability to provide datasets using current industry standards including Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).
- 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.
- Following SAPs, develop specifications and execute derivation algorithms for analysis dataset production.
- Following the SDTM Implementation Guide and written specifications, create programs to produce CDISC-compliant SDTM and ADaM datasets anddefine.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.
- Other duties as assigned.
- Experience working in Pharmaceutical/ Biotechnology/CRO industry as a Statistical SAS Programmer generating TFLs is required (>= 4 years with MS degree; >=6 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.
- 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
- 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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