Job Description
Role Summary
We are seeking a Statistical Programmer with 1–2 years of experience to support clinical trial programming activities within a CRO environment. The role focuses on developing high-quality statistical outputs in compliance with CDISC standards, SOPs, and regulatory requirements , while working closely with biostatisticians and cross-functional teams.
Key Responsibilities
- Develop and maintain SAS programs for clinical trial data analysis
- Create and validate SDTM and ADaM datasets in accordance with CDISC standards
- Generate Tables, Listings, and Figures (TLFs) for clinical study deliverables
- Perform QC and independent validation of datasets and outputs
- Support interim, final analyses , and Clinical Study Reports (CSRs)
- Ensure adherence to SOPs, GxP guidelines, and regulatory standards
- Maintain complete programming documentation and version control
- Collaborate with biostatistics, data management, and clinical teams
Required Skills & Experience
- 1–2 years of hands-on experience in statistical programming within a CRO
- Strong proficiency in SAS (Base SAS, Macros)
- Working knowledge of CDISC (SDTM, ADaM)
- Understanding of the clinical trial lifecycle
- Experience working in a regulated, deadline-driven environment
- Good analytical, problem-solving, and communication skills
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