Statistical Programmer

Required skills:

• Minimum 6 years’ experience as a statistical programming working on clinical trials.
• Good knowledge of TFL programming.
• Experience in programming according to CDISC standards (SDTM, ADaM), and preparing documents for submission (Reviewer’s Guide, Define.xml)
• Attention to details.
• Excellent communication skills.
• A bachelor’s degree in either statistics , computer or life science discipline

Duties will include:

• Participating in all statistical programming activities including preparing clinical data to submission using CDISC or customized standards, reviewing data conversions, data analysis datasets and outputs and taking part in creating best practices and implementation guides.
• Might need to be responsible for project management (timelines, scope, budget, resourcing) on a project or program level.
• Train, mentor and share knowledge with the rest of the statistical programming team.
• Creating programming specification documents for all types of data (SDTM, ADaM, Derived data, etc.).
• Might include Interaction with customers on a project or program level.
• Development of SAS programs for conversion of the clinical data based on CDISC or customer instructions.
• Development of SAS programs for analysis datasets based on SAP, shells and CDISC or customer instructions.
• Development of SAS programs for study TFLs, based on study SAP and shells.
• Review and verify all types of conversions and programming done based on customer requirements.
• Development of core programs for validation, conversion, and maintenance of clinical data dataset structure.
• Follow the appropriate Standard Operating Procedures (SOPs) for all statistical programming related activities.