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. As a Principal Statistical Programmer, you will be dedicated to one of our global pharmaceutical clients.
Responsibilities
You will be responsible for completion of the following:
- Create, validate, execute and generate statistical programs consisting of listings, safety and efficacy outputs (analysis datasets, tables, figures)
- Create and finalise project or departmental level macros
- Create and finalise programming specifications/mock-ups
- Generating accurate, complete and consistent outputs in accordance with documented procedures and project specific timelines
- Leading programming deliverables for at least one study of moderate complexity and/or scope including effective resource planning
- Tracking and work allocation to ensure project, timeline and quality goals are consistently achieved.
Additionally, you will contribute to the review and quality control of programming deliverables, including statistical programs and supporting specifications and documentation. You will effectively liaise with other functions in the conduct of programming activities and support other project activities such as addressing audit findings and facilitating flow of study budget information, as required.
Qualifications
- A strong communicator with a proactive nature and a willingness to work as part of a team
- A minimum of 5 years relevant experience of successfully performing the role of Statistical Programmer, preferably in the clinical research industry
- Good understanding of global clinical trial practices, procedures, methodologies and regulatory
- Experience with R programming is essential
- requirements (e.g., GCP, ICH)
- Good working knowledge of the types of risks associated with a study and the impact on key
- parameters, such as study timelines
- Strong working knowledge of statistics and statistical software packages
- Strong SAS programming skills
- Good working knowledge of statistical concepts
- Strong working knowledge of data structures (e.g., CDISC SDTM, ADaM), software development lifecycle and their implementation
- Strong working knowledge of the development and use of standard programs and macros
- Ability to critically review data and implement corrective action steps effectively
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