Clinical SAS Programmer - REMOTE
- Cambridge, MA 02142
Sr. Clinical SAS Programmer - REMOTE
• Collaborate with the Programming Leader to provide support for aspects of the clinical development process, including clinical development plans, regulatory submissions, commercialisation and scientific utilisation data for products.
• Collaborate with the Programming Leader to provide programming support to deliver technical programming and information components of a project, including but not limited to: o Regulatory response to agency queries o Development Safety Update Reports (DSUR) o Periodic Benefit-Risk Evaluation Report (PBRER) o Investigators brochures (IB) o Data submission strategy, i.e., legacy data, pooling data, communications with regulatory agencies o Outcomes studies o Pharmacokinetics/pharmacodynamics data preparation and analysis o Manipulating and analyzing adjudicated data o Delivering Clinical Trial Transparency (data de- identification) o Data preparation and analysis for Global Medical Affairs work
• Produce and maintain the technical database standards and Programming Specification documents
• Contribute to 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
• Provide support to the regulatory submissions including specification and delivery of overview databases, outputs 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 Contributes to innovating and streamlining workflows
o Knowledgeable of the drug indications within a therapeutic area and data submission standards within that therapeutic area.
o Contributes to assessing and mitigating risk within a protocol or drug project and proactively determining the need and/or level of escalation
• BSc in Mathematical, Statistical, Computer Science or Life Science
• Extensive SAS programming experience
• Knowledge of database set-up and report publishing requirements
• Knowledge of technical and regulatory requirements related to the role
• Knowledge of CDSIC standard and industry best practices
• Experience in clinical drug development or healthcare
• Excellent verbal and written communication skills
• Leadership role able to lead and direct elements of project work
• Accountable for the quality of elements of project programming work
• Accountable for good Information Practice
• Collaboration required
• Ability to apply programming expertise to problems, problem solving and quality focus.
• Other programming languages e.g. S-PLUS, R, XML etc.
• Familiarity with Open CDISC Validator