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.