Statistical Programmer II SDTM

Statistical Programmer II SDTM

Docs Global

Statistical Programmer – SDTM

Responsible for the integrity of the programming/computing solutions for multiple clinical trials (or equivalent) and/or publication activities.
In collaboration with the Biostatistician and Senior Programmer, provide programming support to project-level programming deliverables and other adhoc programming requests.
Ensure understanding and compliance with study and project programming standards. Responsible for development of programming specification.
Create and Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy.
Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy.
Create Crf annotations define.xml and write specifications.
Create Study specific or general macros and finalize programming specifications/mock-ups.
Adhere to programming specifications and study specific requirements, including completion and filing of required documentation.
Plan and organize workload to ensure effective time management and adherence to project specific timelines.
Proactively plan for and implement effective resource planning, task allocation and tracking of workload in accordance with agreed KPIs and quality standards
Trouble-shoot and resolve programming issues in a timely and efficient manner.
Ability to work independently and as part of a team environment.
Strong problem solving and organizational skills, attention to detail, verbal and written communications skills


4+ years’ work experience in a SDTM programming.
Create CRF annotation develop specifications and Run Pinnacle report
Create and Validate Safety and Efficacy Tables, Listings and Figures with high quality and accuracy.
Experience in creation of SDTM Datasets and define.xml
Very strong SAS programming skills required in SAS/Base, PROC SQL,SAS/Stat, SAS Macros and SAS/Graph (Base and Advance SAS).
Good communications and negotiation skills, ability to work well with others globally.


University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree

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