Overview
We are looking for a skilled Statistical Programmer to join our clinical programming team and support high-quality statistical deliverables for clinical trials.
Responsibilities
* Develop, validate, and maintain SAS programs to generate clinical datasets, tables, listings, and figures (TLFs) according to study protocols and statistical analysis plans.
* Create SDTM and ADaM datasets compliant with CDISC standards.
* Perform quality checks and validation of statistical outputs.
* Collaborate with biostatisticians, data managers, and clinical teams to ensure accuracy and compliance with regulatory requirements (FDA, EMA).
* Prepare programming documentation in line with SOPs and regulatory guidelines.
* Participate in code review and process improvement initiatives.
Requirements
* Bachelor’s degree in Computer Science, Statistics, Mathematics, Life Sciences, or related field.
* 2–4 years of experience as a Statistical Programmer in the pharmaceutical, biotech, or CRO industry.
* Strong knowledge of SAS Base, SAS Macro, and SAS/SQL.
* Experience with CDISC SDTM and ADaM implementation.
* Understanding of clinical trial processes and regulatory submission requirements.
* Strong problem-solving skills, attention to detail, and ability to work independently.
Desirable Skills
* Familiarity with Pinnacle 21 and FDA/EMA submission standards.
* Experience with SAS/Graph and ODS for reporting.
* Knowledge of oncology, cardiovascular, or other therapeutic areas.
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