Technical Data Architect II (Senior SDTM Programmer)
- Experience Level
- Experienced (non-manager)
This is an exciting opportunity to join one of the top UK pharmaceutical companies, dedicated to creating and delivering innovative pharmaceutical health care solutions that enable people to live longer and healthier.
Roles & Responsibilities of the position
•Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.
•Read, ensure understanding and adhere to all assigned ICON and/or Sponsor SOPs and working procedures (as appropriate).
•Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
•Complete all assigned trainings and courses in the ICON Training Management system (iLearn) (and / or sponsor system, as appropriate); ensuring all mandatory courses are completed before the designated date and that the required system specific training has been completed for current studies.
•Record all billable and non-billable time in the appropriate timesheet management system.
•Lead and execute programming deliverables on two projects of high complexity and/or at least three projects of moderate complexity in parallel and ensure that competing priorities are managed appropriately. May act as overall Programming Lead for a complete program of studies for a small/moderate project.
•Lead and manage the assigned programming team's deliverables at the study and program level to ensure project objectives are met within budget, to agreed timelines and to the highest standard of quality.
•Proactively plan for and implement effective resource planning, task allocation and tracking of workload in accordance with agreed KPIs and quality standards
•Serve in a client-facing capacity that demonstrates the ability to anticipate client needs and implement innovative solutions, as appropriate.
•Develop and foster client relationships through effective project management and communication.
•Keep management informed of project status in relation to quality, timelines and/or performance issues.
•Monitor programming activities in terms of added value and controlling costs, as required.
•Deliver high quality statistical programming outputs for all assignments that consistently meet study ti
University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree
At least 5 years of relevant experience in pharmaceutical industry is desired, experience in other industries in Data Engineering role will also be considered as well as the following:
•In-depth knowledge of protocol, current clinical drug development processes.
•Working knowledge of eDC systems, Rave is desirable.
•In-depth programming skills SAS, SQL or other languages R, Python, etc.
•Expert knowledge of SAS programming, Define.xml, SDTM aCRF, cSDRGs.
•Expert knowledge of data structures (e.g., CDISC SDTM, ADaM), software development lifecycle and their implementation.
•Ability to work with cross-functional team interpreting data requirements.
•Strong project management skills and knowledge of team management principles are required.
•Aptitude and motivation learn new technologies and make appropriate recommendations for consideration is preferred.
•Prior experience of leading a programming team to manage timelines, resources and overall quality in a client-facing capacity (project leadership track only).
•Demonstrated ability to successfully manage complex assignments, including competing tasks and timelines.
•Ability to liaise successfully with team members, management and externally with vendors and sponsors, as required.
•Advanced problem solving and organizational skills, attention to detail, verbal and written communication skills.
•Good understanding of global clinical trial practices, procedures, methodologies and regulatory requirements (e.g., GCP, ICH).
•Strong working knowledge of the types of risks associated with a study and the impact on key parameters, such as study timelines (project leadership track only).
•Demonstrated ability to learn new applications and techniques.
•Advanced/expert-level (project leadership/technical track, respectively) workin
Remuneration & other details
• Competitive salary
• Home -Based
• Permanent Position