SDTM Programmer

Role & responsibilities

Annotate CRFs in accordance with CDISC standards.

Develop validate and review SDTM domains.

• Ensure compliance with the SDTM Implementation Guide and regulatory

authority submission guidelines.

• Prepare submission deliverables including P21 define.xml and SDRG.

• Utilize advanced SAS programming skills to support data management

and analysis.

• Collaborate with cross-functional teams to ensure data integrity and

quality.

Qualifications:

• Minimum of 6 years of relevant experience in SDTM programming.

• Strong understanding of CDISC standards including the SDTM

Implementation Guide.

• Hands-on experience in developing validating and reviewing SDTM

domains.

• Sound knowledge of submission deliverables including P21 define.xml

and SDRG.

• Advanced SAS programming skills; working knowledge of SQL and

Python is an added advantage.