Sr Clinical Data Programmer (SAS)

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Senior Clinical Data Programming Lead role will be part of the ICON Medical Imaging Reporting & Analytics team responsible for clinical data specifications, SAS programming and delivery. To effectively assist the Director, Technical Management in leading the activities for those under his/her jurisdiction in a manner that ensures all timeframes and targets are met and that costs are kept under control.

The Senior Clinical Data Programming Lead is responsible for managing multiple clinical data delivery projects in accordance with established timelines, budget, quality standards and/or contractual requirements.
The Senior Clinical Data Programming Lead participates in activities as related to the specification, validation and quality assurance of study data deliverables and applies expert experience and knowledge in support of the clinical data programmers assigned to a clinical study.

* Creates and reviews deliverables such as Criteria Check Specifications and Report Requirement Specifications.
* Creates/Programs edit checks, special actions/functions, custom programs and derivations as per specification.
*Plans and schedules edit check test script writing, edit check programming and edit check validation. Manages timelines for edit check process, ensures issues are addressed in a timely manner to meet timelines and produces edit check validation packages for delivery to the study teams to file in the Trial Master File.
*Completes study database reporting updates as specified per Change Request documents and procedures.
*Serves on project teams to coordinate and lead activities for clinical database programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
*Trouble-shoots and solves study building issues and/or system integration issues, and/or change request issues using the appropriate applications.
* Creates advanced SAS custom programs as per specification, as required.
* May participate in study team meetings as an ad hoc study team member to advise study team on best approach/tool for data collection, to determine scope and limitations of the study and to discuss edit checks, derivations , testing and reports.
* Ensures high quality deliverables by providing senior review of study-level/program -level I multi­ study core deliveries for accuracy.
* Participates in special projects or tasks as directed by the Director, as required. This can involve taking ownership of planning, maintenance and delivery of special projects while keeping management informed of the progress.
* Attends sponsor audits and assists with in-house audits, including the reporting process

* Maintain confidentiality of management information as appropriate.
* To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features. Participate in Technical Management department initiatives.
* Plan for the study execution in detail thereby providing clarity on all aspects of the setup progress (Round 1 programming date, testing dates, UAT dates)
* To act as a bridge between the Programmers and TPM group. Addressing technical clarifications and providing guidance as needed.
* Maintaining all necessary study documentation for the CRF build and edit checks.
* Keeps up-to-date with all software developments and release notes of assigned primary systems. Research and self-training is required to ensure that knowledge, particularly in relation to system functionality, is current.
* Ensures all queries to the group are responded to in a timely manner, particularly when trouble-shooting an issue or answering a system functionality question. Ensures that queries that cannot be resolved are routed to the correct SME and the issue is pursued until resolved.
* Contributes to training materials on a process, system or technology level. Works with ICON University and TM Management on delivery of training courses, instructor-led and on-the-job.
* Ensures programming processes are compliant with applicable SOPs.
* Respond to Business Development requests as required
* Administrative responsibilities include projecting the planning and tracking of projects, resource allocation, and supervision of programmers, medical terminologists, and/or forms designers.
* Participates in task assignment activities where required and acts as a back-up in Directors absence
* Ability to retrieve raw datasets.
* Other responsibilities may be assigned as required.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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