SDTM Programmer - (Home based across South Africa) at ICON plc

All our team members have the independence to get the job done with support from the experienced leadership team when you need it. If you want a career with a difference, ICON Strategic Solutions is the place for you.

Looking for an exciting new position? ICON Strategic Solutions is recruiting for a home-based opportunity as STDM Programmer!

Responsibilities

• Applies extensive domain and therapeutic knowledge in the programming of SDTM datasets to ensure quality and accuracy.
• 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
• The Lead SDTM is required to attend study related meeting and study kick off meeting for each study.
• Collaborate with key stakeholders to understand dataset requirements for SDTM production
• 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
• Deliver high quality SDTM datasets to stakeholders according as per agreed timelines
• Develop SDTM work package for pipeline clinical studies in accordance with CDISC/Biogen-defined data standards, processes, and implemented technology solutions
• Lead SDTM may answer all questions from study team (Biostatistician and Statistical programming) and set up any meetings as needed.
• Validate datasets using P21 and provide solutions to the issues and deliver high quality datasets.
• Maintain and address all the Raw and SDTM issues captured in finding log.
• 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
• Adherence to Biogen standard operating procedures, guidance documents and policies; metrics and quality measures

You have:

• Bachelor degree in Computer Science, Statistics, Mathematics, or other subject with high statistical content (Master degree preferred)
• 8+ years programming experience
• Strong documentation, communication, enthusiasm, and time management skills are essential
• Epidemiology Programming using SAS Pharmaceutical industry experience
• Prior experience with large databases and observational research/epidemiology methods is strongly desired.
• 6 plus years Pharmaceutical/CRO industry experience
• Excellent oral and written communication skills
• Good planning and project management skills
• Ability to collaborate and work well in a team environment
• Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
• Experience in using additional software tools and applications (e.g. MS office, XML)
• In-depth understanding of regulatory, industry, and technology standards and requirements.

What we offer :

• Fully home based role in Soth Africa.
• Full time permanent position
• Part of a TOP 5 CRO (ICON Clinical), working within ICON ISS Unit (largest FSP unit) on FSP Basis for a well-known global biotech company.
• Attractive compensation package & benefits; trainings and career development opportunities.