Clinical SAS Programmer - REMOTE

Raleigh, NC 27513

Post Date: 06/30/2018 Job ID: 30120 Industry: Other Area(s)

Sr. Clinical SAS Programmer - REMOTE

100% 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

Required:

• 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
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