Principal Statistical Programmer

• Support all programming activities required for the data analysis of the clinical trials and create standard datasets (SDTM) and analysis datasets (ADaM) and generate reports of the form Tables, Listings and Graphs are applicable.
• Support other documentation tasks such as Define, RGs and CRT packages as required for the reporting of clinical trials.
• Collaborate with other statistical colleagues and study personnel to provide input to statistical analysis plans.
• Assist in and/or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the data analysis plan, and conducting the actual analysis once a reporting database is created.
• Collaborate with data management in the planning and implementation of data quality assurance plans.
• Maintain proficiency with respect to SAS programming and statistical methodology and in applying new and varied methods.
• Effectively justify methods selected and implement previously outlined analysis plans.
• Conduct peer-review of work products from statistical colleagues.
• Effectively utilize current technologies and available tools for conducting the clinical trial analysis. Communication of Results and Inferences
• Collaborate with other statistical colleagues to write reports and communicate results.
• Responsible for assisting in the communication of study results via regulatory submissions, and manuscripts, as well as for communicating one-on-one with key customers.
• Assist or respond to regulatory queries working in collaboration with other statistical colleagues. Therapeutic Area and Systems Knowledge
• Understand relevant disease states in order to enhance the level of customer focus and collaboration.
• Ensure replication of tools and systems, where applicable and stay informed of technology advances.

Regulatory Compliance

• Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes and training.

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