Specialist Programmer

SRG Clinical
Macclesfield, UK
27 Aug 2019
13 Sep 2019
Contract Type
Full Time
SRG are working on behalf of a Global Pharmaceutical Company who have opened a new vacancy within their team and are looking to recruit a Specialist Programmer on an initial 10 Month contract basis to work remotely (this is a home-based role)

  • 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 company 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:
  • Regulatory response to agency queries
  • Development Safety Update Reports (DSUR)
  • Periodic Benefit-Risk Evaluation Report (PBRER)
  • Investigators brochures (IB)
  • Data submission strategy, i.e., legacy data, pooling data, communications with regulatory agencies
  • Outcomes studies
  • Pharmacokinetics/pharmacodynamics data preparation and analysis
  • Manipulating and analysing adjudicated data
  • Delivering Clinical Trial Transparency (data de- identification)
  • 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

  • Knowledgeable of the drug indications within a therapeutic area and data submission standards within that therapeutic area.
  • Contributes to assessing and mitigating risk within a protocol or drug project and proactively determining the need and/or level of escalation
  • 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
  • Assist in developing and delivering training


BSc in Mathematical, Statistical, Computer Science or Life Science.

If you are interested in this role or would like to have a confidential career discussion regarding other Opportunities. Please contact me: or +441753 589673

This job was originally posted as www.totaljobs.com/job/87639682

Similar jobs

Similar jobs