Overview
As a Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing:
- Creation of ADaM datasets based on current ADaM standards.
- Creation of Tables, Listings and Figures following sponsor specifications
- Creation of Subject Narratives following templates to support Narrative development.
- Creation of other ancillary data streams including (but not limited to) clinical registry reporting files (e.g. Clintrials.gov, EudraCT), Bioresearch monitoring reports (BIMO).
- QC of all programmed output
- Creation and/or maintenance of detailed specification documentation
- Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencies as needed.
- Includes support for standalone studies as well as integration of data across studies.
Qualifications
You are:
- Minimum 4+ years of experience
- High level experience in the implementation of SAS (Base and Macro) in the analysis of clinical trial data
- Working knowledge of clinical trial data (Study population, safety, efficacy, PK/PD) in the therapeutic are being serviced.
- Demonstrated understanding of current industry standards for submission of clinical trial data.
- Specific for CDSA – Analysis Standards focus area:
- Basic knowledge in industry standards, specifically Study Data Tabulation Model (SDTM), Controlled Terminologies (CT) and related Analysis Data Models (ADaM)
- Relevant operational experience in analysis standards (ADaM metadata and SAS Code) is preferred.
- Experience with Therapeutic Area User Guides (TAUG) is a plus
What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested 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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