Job Description

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

1. Conduct analysis of current business processes and workflows
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

1. Proficiency in business process modelling tools such as bpmn or uml
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

Other Requirements

1.Business Process Modelling certification (e.g., BPMN 2.0)