Stats/SDTM Programmer

Job Description :

Role : Stats Programmer / SDTM Programmer

Experience : 8 to 13 Years

Key Responsibilities :

- Develop SAS programs for analysis datasets (ADaM/SDTM) and TLF outputs.

- Validate analysis datasets and outputs.

- Support e-submission preparation and review.

- Review key planning documents (SAP, data plans) and assess programming impacts.

- Interact with vendors for standards and file transfers.

- Ensure high-quality GBDS deliverables aligned with regulatory standards.

- Identify efficiency and consistency improvements.

- Lead programming assignments independently.

- Support process improvement initiatives.

Required Skills :

- Bachelors degree in Statistics, Biostatistics, CS, Mathematics, or Life Sciences.

- Minimum 8 years of programming experience in clinical research.

- Strong analytical programming proficiency.

- In-depth understanding of CDISC, relational databases.

- Experience with MS Office, XML, Pinnacle 21.

- Expertise in upstream data handling (eDC, SDTM).

- Experience producing ADaM datasets, Define.xml, submission deliverables.

- Knowledge of regulatory standards, clinical tests, and terminology.

- Strong team collaboration skills.

Preferred :

- 8+ years of clinical/statistical programming experience.

- Experience supporting regulatory filings (NDA/BLA/MAA).

- Experience with R and Linux OS.