Principal Statistical Programmer

Responsibilities :

• Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.
• Be responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables.
• Create statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts, and other clinical publications; support systems to produce electronic regulatory submissions.
• Assist in establishing standardized programming procedures and work instructions.
• Develop, enhance, evaluate, and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation / compliance activities.
• Develop and maintain clinical processing workflow systems.
• Assist in the development of client proposal documents.
• Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
• Provide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets.
• Trained in sponsor SOPs and disseminate knowledge to project team members as appropriate.
• Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (, biostatisticians, data managers, medical writers, etc.) records handling (, Chapter of the US Code of Federal Regulation – Part ), and electronic submission of clinical data to agencies (, e-CTD guidance and CDISC SDTM and ADaM standards).
• Assist in updating / writing PROMETRIKA standard operating procedures (SOPs).
• Develop tools in SAS for data analysis and reporting that comply with regulatory requirements.
• Develop specifications (, metadata files), annotate CRFs and create SAS programs for the mapping of raw datasets to CDISC SDTM standards.
• Create files from metadata files for SDTM and ADaM.
• Convert data received in other formats to SAS datasets.

Requirements :