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A recruitment platform is seeking a skilled Statistical Programmer to support statistical deliverables for clinical trials. The role involves developing and validating SAS programs, ensuring compliance with CDISC standards, and collaborating with clinical teams. The ideal candidate has a Bachelor's degree in a relevant field and 2-4 years of experience in the pharmaceutical or CRO industry.
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.