As a Statistical Programmer in a Pharmaceutical Company, you will play a crucial role in supporting clinical trial data analysis and regulatory submissions. You will be responsible for programming, validating, and documenting datasets and statistical outputs to ensure accuracy and compliance with industry standards.

Key Responsibilities

- Develop, test, and validate SAS and/or R programs for clinical data processing and analysis.

- Create, maintain, and document datasets (SDTM, ADaM) per regulatory and company requirements.

- Generate tables, figures, and listings (TFLs) for clinical study reports.

- Collaborate with statisticians, data managers, and clinical teams to ensure data quality and integrity.

- Participate in the review of statistical analysis plans, CRF, and other study-related documents.

- Maintain strict adherence to GCP, FDA, EMA, and ICH guidelines.

- Contribute to data submission packages and regulatory interactions.

- Manage timelines and workload to ensure project milestones are met.

Must Haves

- Bachelor’s or Master’s degree in Statistics,



Mathematics, Computer Science, Life Sciences, or related field.

- Proficiency in SAS programming (Base, Macro, and SQL).

- Solid understanding of clinical trial data structure and regulatory requirements.

- Experience with SDTM and ADaM dataset creation.

- Familiarity with CDISC standards.

- Strong written and verbal communication skills.

- Attention to detail and ability to work independently or as part of a team.

Nice to Haves

- Experience in R programming or Python.

- Prior experience with submissions to FDA/EMA.

- Exposure to oncology, rare diseases, or other specialized therapeutic areas.

- Knowledge of statistical methods for clinical trials and ability to review statistical outputs.

- Familiarity with other data visualization tools (e.g., Spotfire, Tableau).

- Experience in automation and process optimization.

- Previous experience in a CRO or pharma environment.

📌 Statistical Programmer (Colombia)
🏢 Kelly Science, Engineering, Technology u0026 Telecom
📍 Colombia