Statistical Programmer
Core
Develop and validate SDTM and ADaM datasets, tables, figures, and listings for clinical trial analyses and regulatory submissions.
Role type
Junior Statistical Programmer (Clinical Trials)
Builds
Regulatory-ready analysis datasets and outputs for oncology clinical studies
Domain
Biopharmaceuticals / Clinical Data Management
Required skills
SAS programming, CDISC standards (SDTM, ADaM), dataset validation, regulatory submission preparation, cross-functional collaboration
Preferred skills
Oncology study experience, clinical trial design knowledge
Technologies
SAS, XML
Responsibilities
Generate or validate SDTM and ADaM datasets and Define.xml files; Develop and validate tables, figures, and listings for clinical study analyses; Write SAS programs and macros to automate dataset creation and reporting deliverables; Review study documents including statistical analysis plans and database specifications; Evaluate the quality, integrity, and consistency of analysis datasets; Attend study team meetings and represent statistical programming in cross-functional discussions.
Seniority
Junior, 0–2 years experience
