Sr. Statistical Programmer

What You'll Do:

The Senior Statistical Programmer generates 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.
• 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.
• Other duties as assigned.

How You'll Get There:

• 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