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 :