:

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.




- Robust 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.

📌 Stats/SDTM Programmer (India)
🏢 Innova Solutions Private
📍 India