CK Group is recruiting for a Specialist Programmer to join a company in the Pharmaceutical industry on a fully remote, contract basis for 12 months and has an hourly rate of £50 for a Programmer, £60 for a Senior Programmer and £65 for a Principal Programmer.
The Company: Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.
The Role: As a Specialist Programmer you will 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.
You will also 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 analyzing adjudicated data.
- Delivering Clinical Trial Transparency (data de- identification).
- Data preparation and analysis for Global Medical Affairs work.
Further duties include:
- 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.
Your Background: To be considered you should have the following key skills, knowledge:
- 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.
- Late Stage Oncology experience.
For more information or to apply for this position, please contact Jenni on 01438 768 710 or email email@example.com. Alternatively, please click on the link below to apply online now. 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 47475 in all correspondence.