Kavaliro Cary , NC 27513
Principal Clinical SAS Programmer - (REMOTE)
This role will act as the strategic computer programming leader to provide support for all aspects of the clinical development process including, but not limited to, clinical development plans, regulatory submissions, programming and information deliverables, commercialization and scientific utilization data for products. Lead the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases by these partners.
Oversee the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable. Lead programming support to the regulatory submissions including specification and delivery of overview data bases, output and response to regulatory questions. Identify opportunities to improve the methodology and provide practical solutions for problems.
Contribute to the development of best practice to improve quality, efficiency and effectiveness. Required: O Able to leverage experience to innovate and streamline workflows o Knowledgeable of the drug indications within a therapeutic area, their analysis trends, and their effects on data submission standards. o Able to effectively assess and mitigate risk within a protocol or drug project and proactively determine the need and/or level of escalation BSc in Mathematical, Statistical, Computer Science or Life Science Extensive Clinical SAS programming expertise to an advanced level Comprehensive knowledge of technical and regulatory requirements related to the role Knowledge of CDSIC standards and industry best practices Extensive experience in clinical drug development or healthcare Experience in Regulatory submissions Excellent verbal and written communication skills and influence stakeholders Lead the development and delivery of training Excellent collaboration required needs the energy to work across global & functional boundaries Ability to apply programming expertise to problems, problem solving and quality focus. Other programming languages e.g.
S-PLUS, R, XML etc. Extensive knowledge of Open CDISC Validator