A global biopharmaceutical company is advertising a vacancy for a Specialist Programmer in a remote capacity. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.
- 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:
- 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
- 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 and Requirements:
- 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.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tom Magenis at +44 203 854 1050 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.