Stephanie Maccioni is currently recruiting for a Principal Specialist Programmer to join a global Pharmaceutical company for a 12 month contract. The position offers remote working.
Main duties and responsibilities:
·Collaborating with the Programming Leader to provide support for aspects of the clinical development process, including development plans, regulatory submissions, commercialisation and scientific utilisation data for company products.
·Producing and maintaining the technical database standards and Programming Specification documents
·Contributing 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
·Providing support to the regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions
·Identifying opportunities to improve the methodology and providing practical solutions for problems
·Contributing to the development of best practice to improve quality, efficiency and effectiveness
·Experience with CDISC standards and implementation (both SDTM and ADaM)
·Experience with reviewing vendor deliverables
·Experience creating Tables, listings, figures for individual studies and for pooled studies
·Experience creating and/reviewing define.xml files, pinnacle 21 checks (formerly opencdisc)
·Experience Creating and/or reviewing Study data reviewer's guides and Analysis data reviewer's guides
.Oncology experience preferred
A full job spec is available upon request
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL39488 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 4th July 2017
- Expires: 1st August 2017
- Reference: CL39488