Senior Statistical Programmer I

2 weeks ago

Johannesburg, South Africa ICON plc Full time

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.
- Creation of ADaM datasets based on current ADaM standards
- Creation of Tables, Listings and Figures following client specifications
- Creation of Subject Narratives following client templates too 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.
- Bachelor’s degree or higher and / or equivalent in computer science, mathematics or other scientific field (or equivalent theoretical/technical depth).
- Demonstrated written and verbal communication.
- Ability to work remotely
- Knowledge of R is a plus
- 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.

**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.

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