- Clinical SAS Programming
- CDISC Standards (SDTM, ADaM)
- Solid hands-on ADaM Programming
- TLF Development and Validation
- Safety and Efficacy Programming
- SAS Macro Programming
- Independent/Scratch Programming
- Define.xml and Pinnacle 21
- End-to-End Clinical Trial Experience (Phase II/III)
Preferred Skills:
- Oncology/Neurology/Immunology experience
- Reviewer/Lead experience (for senior roles)
- Regulatory submission support
- Strong understanding of derivations, imputations, and analysis datasets
Key Screening Points:
- Hands-on ADaM and TLF experience, not limited to maintenance activities
- Ability to independently develop and validate datasets and outputs
- Strong SAS programming and problem-solving skills
- Experience supporting efficacy analyses
- Candidates should be able to explain their work and demonstrate practical knowledge during interviews