Sr. Statistical Programmer II

How will you make an impact?

The Sr. Statistical Programmer II functions as the lead programmer for assigned clinical studies, who coordinates and oversees the statistical programming activities, such as generating SDTM/ADaM datasets and statistical outputs (TLFs), to support statistical analyses in regulatory submissions, post-marketing, and publications.

What will you do?

• 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.
• Managing/coordinating resources on study basis to ensure high-quality and on-time deliverables of statistical analyses.
• Capable of developing the written specifications based on SDTM/ADaM Implementation Guide and creating programs to produce CDISC-compliant SDTM/ADaM datasets and define.xml files.
• Generate tables, figures, and listings (TFLs) in accordance with TFL shells to support analyses using Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, or other statistical graphics technology.
• Capable of validating SAS programs, macros, datasets, and TFL output generated by other programmers.
• Ensure consistency across programming methods in similar studies within a project.
• Contribute to requests for proposals for programming services from outsourcing vendors. Provide oversight and monitor progress of vendors working on sponsored studies. Develop or assist in the development of departmental processes and procedures.

How will you get here?

• Experience working in Pharmaceutical/Biotechnology/CRO industry as a Statistical SAS Programmer generating TFLs is required (>= 6 years with MS degree; >=8 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.
• Experience programming supporting integrated analyses, e.g. ISS, ISE.
• Good 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.