Principal Statistical Programmer

Bachelors degree from reputable university preferably in
science/ mathematics related fields Preferred SAS certification Technical Skills Requirements Must have expertise of SAS Base, and good knowledge of SAS graph and SAS Macros. Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician. Must have excellent knowledge of CDISC standards (SDTM and ADaM) Thorough understanding of relational database components and theory. Excellent application development skills. Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results. Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes. Experience requirements Minimum of 8+ years of experience in Statistical Programming in pharmaceutical or medical devices industry Desirable requirements Good verbal and written communication skills. Ability to work on multiple projects, plan, organize and prioritize activities. Responsibilities At a minimum, following activities are required to be performed; Perform all responsibilities associated with the Senior Programmer role. Assist all the Sr. Programmers and Programmers in their day to day activities. Act as escalation point for Sr. Programmer and Programmer. Regularly communicates with the sponsor on the progress of programming aspects of the project and proactively anticipates issues and works with the sponsor on resolution of the problems Provide input and/or write the programming specifications Serve as subject matter expert on all aspects of SAS programming Understand pharmaceutical industry standards and trends and proactively plan, develop, and implement Develop consistent practices of clinical and statistical review of output and mentor programming staff Check for consistency across therapeutic areas Identify, plan, and oversee the implementation and success measures of all process improvement initiatives Maintain expertise in the use of the SAS Macros and determine macro development priorities Other responsibilities as defined on ad-hoc basis by senior management. Relationship & Interactions Clinical data manager Biostatisticians Medical Coders