SDTM Programmer

Responsibilities: 

• Providing support for the mapping and transformation of clinical data to CDISC SDTM standards.

 • Create SDTM mappings for conversion of the data. 

• Perform extraction and mapping of the data from an in-house standard to an industry standard format (SDTM). 

• Create the SAS programs to convert the SI data to SDTM format. 

• An understanding of all required SDTM components is essential, including the clinical domain, TDD’s, define.xml, Acrf. Programming experience with SAS is required, the ideal candidate will have a background in clinical programming in a data management setting or statistical setting. The ability to focus on customer needs, troubleshooting and providing innovative technical solutions, while adhering to standards is essential.

 • Integrity check to be performed every month end and the report needs to be reviewed. Required updates to be made in the development file of the respective domain and if no update is required justification needs to be provided against each report. 

• Controlled Terminology mapping to be done if there is a new Controlled terminology referring the QRS mappings standards. 

• Lead and actively participate in review of SDTM conversion deliverables. 

• Create and maintain process documentation as required. 

• SAS programming for creation / review of SDTM domains as required. 

• Create aCRF for SDTM.

 • Create the Define.xml as per the study requirements. • Create the SDRG document. 

• Other activities as required to support SDTM conversion and implementation of CDISC standards.

 Other Responsibilities: 

1. Create & Maintain process documentation as required. 2. Training of new staff in the role required. 

3. To ensure that the timelines of all the deliverables are met with quality as a priority. 4. To communicate with the team members and resolve or escalate queries