Specialist Programmer

Recruiter
SRG Clinical
Location
Macclesfield, UK
Salary
Competitive
Posted
27 Aug 2019
Closes
13 Sep 2019
Ref
1237049850
Contract Type
Permanent
Hours
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)

Responsibilities:
  • 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

Skills:
  • 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

Education:

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

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