Experience: - 4 to 12+ years
Key Responsibilities
- Independently perform SAS programming for SDTM/ADaM datasets and TLFs as per CDISC standards.
- Review and develop study documents: Mapping Specifications, User Guides, Analysis Plans, OCF, and SAS programs.
- Implement QA/QC validation for datasets, tables, listings, and figures.
- Manage client communication and coordinate project timelines.
- Suggest and implement process improvements for enhanced efficiency and quality.
- Mentor and supervise junior programmers, ensuring adherence to standards and timelines.
Required Skills & Experience
- Strong SAS Base, Macros, and GTL programming skills experience in SQL.
- Hands-on experience with SDTM/ADaM datasets and generating TLFs.
- Familiarity with CDISC standards, TAUGs, and clinical trial documentation.
- Experience in define., eSubmissions, and dataset compliance checks is a plus.
- Knowledge of therapeutic areas such as vaccines, I&I, oncology, biomarkers, and PROs is preferred.
- Excellent analytical, problem-solving, and communication skills.
EA Number: 11C4879