Clinical SAS: SDTM/ADAM/TLF

Job Code # 284

Job Location-  Mumbai

Salary- 8 LPA to 12 LPA

Key skills-
a) Bachelors or master’s degree or equivalent in statistics, mathematics, engineering or computer-related subject
b) Experience in Statistical Programming in the clinical domain
c) Experience and understanding of ICH GCP principles and clinical drug development
d) Good knowledge of CDISC SDTM, ADaM & TLF standards

Job Description-
• Minimum of 3 years of experience in the clinical domain is a mandate.
• Experience in Statistical Programming in the clinical domain
• Experience and understanding of ICH GCP principles and clinical drug development process
• Good knowledge of CDISC SDTM, ADaM & TLF standards
• Responsibilities Create derive data specifications as per the standards for SDTM, ADaM datasets, and pooled analysis (ISS/ISE) datasets
• Perform development and/or validation of analysis dataset, tables, listings, and figures for both safety and efficacy parameters
• Be the project lead for statistical programming projects Understand and comply with ICH-GCP guidelines, core operating procedures, and work instructions.
• Ensure all programs are compliant with the SOPs and project-specific guidelines Provide support in developing ad hoc reports as required
• Develop study-level macros as directed by the Senior / Lead Statistical Programmer
• Maintain quality and timelines of programming-related deliverables
• Update project-related documentation regularly
• Track and follow up on all issues raised Escalate unresolved issues to the project point of contact Communicate any data queries or errors to appropriate team members
• Update project-related documentation regularly Handle escalations related to projects
Preferred Educational Qualification for the role:
• Bachelors or master’s degree or equivalent in statistics, mathematics, engineering or computer-related subject