Technical expertise in support of project deliveries and training development of Programming personnel.
Provide technical support, mentoring and guidance in the preparation and review of high quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
Provide high quality, timely support that conforms to current Quanticate (or client-specific) standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
Ensure high levels of customer care are provided.
Deliver excellent customer care in support of genuine value and a great customer experience.
Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.
Comprehensive understanding of current Quanticate, and client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
Good knowledge of pharmaceutical industry standards.
Provide mentoring in area of technical expertise.
Ability to work with different teams, functions, and across sites, as required.
Ability to review clinical documents, e.g. protocol, CRF and SAP.
Perform other reasonable programming tasks as requested by management.
Follow appropriate Project Management procedures.
Work to the appropriate standards of the project.
Demonstrated SAS programming knowledge to an advanced level with expected results in SAS competency test.
Ability to work independently as a programmer.
Provide programming expertise and support within the function on programming standards, processes and procedures.
Provide high quality deliverables and appropriate communication to the client within expected timelines and budget as directed by the Project Lead.
Ability to represent the Company at external conferences and forums, from a clinical programming perspective.
Contribute to SAS training and workshops and other programming-related training sessions as applicable.
Continuous acquirement of SAS and other appropriate programming expertise within pharmaceutical industry.
Key Contacts/Relationships (Internal & External)
Has a close working relationship with Senior Programmers (all levels), line management and other functional staff.
May deputise for a Senior Programmer II.
Works closely with the project study teams (statisticians, clinicians, medical writers, project management) for the successful delivery of programming activities.
Some interaction with clients to complete various programming activities. To fulfil this role, the Senior Programmer I may be required to be a key participant in project team meetings and be responsive on an ad hoc basis.
Qualified to degree level or equivalent, preferably in a numerate discipline.
Understanding of basic statistics.
Preferred 3 years’ programming experience, preferably within the pharmaceutical industry or medical sector.
Knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials.
Preferably have programming experience covering activities from study set-up to final reporting.
Should have PC skills, good knowledge of statistical software packages (particularly SAS), good organisational skills, good communication skills (oral and written), excellent analytical skills, works well as part of a team, and has a continuous improvement mentality and a good attention to detail.