Job Summary
SDTM/Clinical SAS
1.Must have 5-7 yrs of exp in clinical domain
2.Strong knowledge of SDTM
3.Create advanced SAS macros, templates, and utilities for efficient data processing
4.Act as the primary programming point of contact for biostatisticians and study teams
5.Review CRF (Case Report Form) annotations and data specifications.
6.Ensure compliance with CDISC standards (SDTM/ADaM) and FDA/ICH guidelines
Skill:
1.Extensive programming experience in a clinical trial environment (CRO/Pharma).
2.Expertise in SAS/BASE, SAS/STAT, and SAS/MACRO.
3.In-depth knowledge of CDISC standards and regulatory submission requirements
Key Responsibilities
2. Identify opportunities for process improvement and optimization
3. Develop business process models and diagrams
4. Collaborate with stakeholders to gather requirements and understand business needs
5. Define and document business requirements and process improvements
6. Implement and manage process changes
7. Monitor and measure process performance and impact on key metrics
8. Ensure compliance with company policies and industry regulations
Skill Requirements
2. Strong analytical and problem-solving skills
3. Excellent communication and stakeholder management abilities
4. Knowledge of process improvement methodologies like six sigma or lean
5. Experience in data analysis and process mapping
6. Ability to work in a fast paced environment and manage multiple projects simultaneously