Ref #: 31870

Employment type: Permanent - Full-Time

Location: South Africa

Posted: 05-Sep-2021


As part of an ongoing Biometrics and Data Management FSP Partnership with a well known Global Biotech, at ICON Clinical, within our Global Strategic Solutions (GSS) Unit, we are recruiting for experienced SDTM Programmers at Senior, Lead, Principal Programmers levels to join us in Ireland, UK, Western Europe, Poland or South Africa.

Title: Senior, Lead, Principal SAS/SDTM Programmer
Duration: Full Time Permanent Employment
Location: Home Based in UK, Ireland, Belgium, Netherlands, Spain, France, Germany, Poland or South Africa. Other countries in Europe could also be considered on a case to case basis.

Responsibilities / Experience Requirements:

• Initiate SDTM Kickoff meeting with study management team (SMT)
• Set up monthly “Data and SDTM review meetings” for which “Data and SDTM findings log” will be source. Lead will go over the Data issues and get any SDTM findings from SMT team.
• Annotate SDTM CRFs
• The Lead SDTM is also responsible for writing dataset specification and As needed work on Key Domains
• Applies extensive domain and therapeutic knowledge in the programming of SDTM datasets to ensure quality and accuracy.
• The Lead SDTM may lead and execute multiple projects in parallel, including ongoing coaching and mentorship of individual team members.
• Lead SDTM manages task assignments and makes sure that all the support programmers are utilized as needed across multiple projects without compromising quality and timelines of any deliverables
• Collaborate with key stakeholders to understand dataset requirements for SDTM production
• Lead SDTM may answer all questions from study team (Analysis, Biostatistician and programming) and set up any meetings as needed.
• Validate datasets using P21 and provide solutions to the issues and deliver high quality datasets.
• Generate & Validate SDTM Define.xml and provide justifications for any outstanding issues
• Key contributor to SDRG (Study Data Reviewer’s Guide)
• Submit SDTM governance requests for review by Standards SMEs
• Communicates with key stakeholders to aid in further development of SDTM standards and process


Benefits of Working in ICON:

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.

At 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.

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, 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.