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:
- Driving the strategic programming objectives of the designated projects taking into consideration the impact across Development
- Responsible for shaping and driving content and quality of both the clinical data standards and programming deliverables for submissions and authority interactions
- Responsible for ensuring consistency and relevant standardisation across the clinical projects on programming activities based on a thorough analysis and interpretation of internal and external factors
- Being a role model as programming expert, serving as mentor and inspiration for the team
- Leading project teams to achieve milestones and objectives
- Prioritising, planning, managing and executing clinical trials and data submission within project area
- Providing input in programmingSeeking influence in forming the statistical programming strategy in Biostatistics
- Acting as spokesperson on programming aspects on the designated projects
- Driving cross-functional working groups where statistical programming expertise is required
- Further expanding key competences and know-how within statistical programming
- Being an expert within a key process across the SVP area
Required skills and experience:
- +7 years in the biological area doing statistical programming and system development, and of these preferably 5 years within the pharmaceutical industry
- Extensive experience with programming in e.g. SAS or R
- Extensive experience with reporting clinical trials, including statistical data handling, analysis and reporting
- Extensive experience with validation and documentation of programs
- Knowledge specialist of drug development
- Extensive experience with clinical database technologies, data models and advanced programming
- Extensive experience with collaboration across professional and regional borders
- Elevated business insight to proactively deliver required results of key value to stakeholders with a focus on how stakeholders depend on the deliverables
- Extensive experience with communication and presentations
- Experience in supervision and mentoring of programmers
- Regular participation in conferences/workshops
- In-depth knowledge of computer systems and IT
- Profound knowledge of GxP and guidelines within drug development
- In-depth knowledge of CDISC and extensive experience with CDISC ADaM
- Experience with the process of drug applications with the FDA and EMA
- Experience with regulatory deliverables, e.g. documentation of data derivations and programming
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.
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