Principal SAS Consultant- Oncology - REMOTE
One MedImmune Way Palatine, IL 60047
Principal SAS Consultant- Oncology – REMOTE
• 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, commercialisation and scientific utilisation 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.
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 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
• Leadership role able to lead and direct project work
• Accountable for the quality of elements of project programming work worldwide
• Accountable for Good Information Practice
• Reports to Programming Team Leader Other – Capture any additional information you believe would benefit the candidate.
• 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