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Job Description
Structured overview of role & requirementsAbout This Role
Perform statistical programming for phase 1-4 clinical studies to support data analysis and regulatory submissions.
Create and validate clinical trial datasets (SDTM, ADaM) and analysis outputs (tables, listings, figures) for safety and efficacy.
Collaborate globally with cross-functional teams to ensure data quality and compliance using programming tools and documentation.
Minimum Requirements
Bachelor’s degree or higher in biostatistics, statistics, mathematics, computer science, or related quantitative/scientific field.
At least 3 years of statistical programming experience in clinical development environment.
Proficiency with SAS and working knowledge of CDISC SDTM standards; familiarity with ADaM and Define standards.
Located in Hyderabad, India; excellent English communication skills.
Ideal Candidate Profile
Experienced in clinical trial data handling with strong expertise in SAS programming and regulatory submission support.
Able to work effectively in a globally dispersed, cross-cultural team managing multiple projects.
Familiar with data quality tools and the drug development lifecycle, with capability to meet challenging timelines.