- Develop, validate, and maintain SAS programs for clinical trial data analysis.
- Generate Tables, Listings, and Figures (TLFs) based on Statistical Analysis Plans (SAPs).
- Create SDTM and ADaM datasets in compliance with CDISC standards.
- Perform data validation and quality checks to ensure programming accuracy and data integrity.
- Collaborate with Biostatistics, Data Management, and Clinical Operations teams.
- Troubleshoot programming issues and provide timely solutions.
- Maintain programming documentation in accordance with SOPs and regulatory requirements.
Required Qualifications:
- Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.
- 2-3 years of statistical programming experience in the pharmaceutical, biotechnology, CRO, or IT industry.
- Robust proficiency in SAS (Base SAS, SAS Macro, and PROC SQL).
- Experience in TLF programming and generation.
- Good understanding of CDISC standards, including SDTM and ADaM.
- Familiarity with ICH-GCP guidelines and regulatory requirements (FDA, EMA).
- Knowledge of clinical trial processes and statistical concepts.
Preferred Skills:
- Strong analytical and problem-solving abilities.
- Excellent attention to detail.
- Good communication and technical documentation skills.
- Ability to work independently as well as in cross-functional teams.
- Effective time management and multitasking capabilities.
Technical Skills:
- SAS (Base SAS, Macro Programming, PROC SQL)
- TLF Programming
- CDISC SDTM & ADaM
- Microsoft Excel
Nice-to-Have Skills:
- Knowledge of R programming.
- Experience with Define.xml generation.
- Exposure to regulatory submissions (eCTD).
- Understanding of clinical trial data management and EDC systems.
Experience
- 2-3 years of relevant statistical programming experience in clinical research.
Location
- PAN India
📌 Statistical Programmer 1 (Faridabad)
🏢 JSS Medical Research
📍 Faridabad
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