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 organisations. With our patients at the centre 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.
Responsibilities:
- Planning, managing and execution of statistical programming deliverables in clinical trial and non-trial activities in the project
- Providing input to authority required documents for the trial and non-trial activities
- Ensuring that clinical trial and non-trial tasks are aligned with the project specifications
- Responsibitly for continuous development of own skills and to contribute to the development of Biostatistics
- Providing programming input to the setup of the trial, including but not limited to the CRF, Trial Validation Plan and Data Flow Plan
- Ensuring that mock TFLs are created and reviewed by stakeholders
- Making AdaM programming according to industry standard and NN specifications
- Ensuring that programming, also by co-workers and functional suppliers, is done according to specifications
- Ensuring that the inspection readiness documentation is updated at all time during the trial life cycle
Required skills and experience:
- +3 years of statistical programming, and preferably 1 year within the pharmaceutical industry or equivalent knowledge through relevant experience
- Extensive experience with programming in e.g. SAS or R
- Experience with reporting clinical trials, including statistical data handling, analysis and reporting
- Experience with review and documentation of programs
- Good knowledge of drug development
- Experience with clinical database technologies, data models and advanced programming
- Experience with collaboration across professional and regional borders
- Regular experience with communication and presentations
- In-depth knowledge of computer systems and IT
- Good knowledge of GxP and guidelines within drug development
Why 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.
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.
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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
