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Job Description
Structured overview of role & requirementsAbout This Role
Perform hands-on statistical programming for clinical trial data analysis and regulatory submissions across phases 1 to 4.
Create and validate SDTM, ADaM, analysis datasets, and safety/efficacy tables, listings, and figures.
Maintain tracking and validation documentation and collaborate with cross-functional global teams for data quality checks.
Minimum Requirements
Bachelor's degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific fields.
At least 3 years of statistical programming experience in a clinical development environment.
Working knowledge of CDISC SDTM standards; familiarity with ADaM and Define standards for dataset creation and validation.
Ability to work globally with dispersed teams and manage multiple projects effectively.
Ideal Candidate Profile
Experienced in clinical trial operations with strong expertise in SAS programming and statistical data reporting.
Familiar with drug development lifecycle and regulatory submission processes.
Comfortable working in cross-cultural teams with strong communication skills, and adept at implementing data quality and compliance checks.