Job Description
We are looking for a highly experienced Clinical Statistical Programmer to independently lead programming activities across clinical studies. This role requires deep expertise in SDTM and ADaM dataset development, complex TLF generation, and regulatory submission support.
Key Responsibilities
- Design, develop, and validate SAS programs for SDTM, ADaM, and TLF outputs
- Produce submission-ready datasets and documentation, including Define.xml
- Review and interpret SAPs and data management plans to determine programming requirements
- Ensure deliverables comply with CDISC and regulatory standards
- Lead programming activities for assigned studies with minimal supervision
- Collaborate with cross-functional teams and external vendors on data standards and transfers
- Perform quality control and validation of datasets and outputs
- Identify and implement process improvements to enhance efficiency and ...
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