As a Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. We are looking for a Statistical Programming for clinical trials Phase I – IV utilizing SAS (Base and Macros) and R.
ResponsibilitiesWhat you will be doing:
• Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
• Creation of ADaM datasets based on current ADaM standards.
• Creation of Tables, Listings and Figures following client 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.
• Specific for CDSA – Analysis Standards focus area:
oThe service holder is responsible to design, develop and maintain SAS code that is generic and that covers many trial types, can run on many study designs and meet study specific situations based on high reliable study metadata specifying the design and study specific situations.
o The service holder defines and maintains standard clinical data analysis metadata for use in clinical trials, including the traceability from Analysis Datasets and Analysis Results (ADaM) to Study Data Tabulation Datasets (SDTM).
o The service holder pre-configures the standards in line with the data lifecycle plan while maintaining the traceability and lineage of the data. The service holder documents and correctly manages the lineage between master standards and the many pre-configured standards.
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:
o Basic knowledge in industry standards, specifically Study Data Tabulation Model (SDTM), Controlled Terminologies (CT) and related Analysis Data Models (ADaM)
o Relevant operational experience in analysis standards (ADaM metadata and SAS Code) is preferred.
o Experience with Therapeutic Area User Guides (TAUG) is a plus.
• Bachelor’s degree or higher and / or equivalent in computer science, mathematics, or other scientific field (or equivalent theoretical/technical depth). Advanced degree (Master's, PhD or equivalent) preferred for Level 4.
• Demonstrated written and verbal communication.
• Ability to work remotely.
• Knowledge of SAS is must and R, Python 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:
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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, 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.
https://careers.iconplc.com/reasonable-accommodations
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.