Statistical Programmer

Overview

We are looking for a skilled Statistical Programmer to join our clinical programming team and support high-quality statistical deliverables for clinical trials.

Key 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.