Clinical Data Programmer I (SDTM)
IndiaFull-time2–5 yrsPosted 2 months ago
Mid-level pharma role at Fa Euzi Saasfaprod1. Needs 2+ years and a B.Tech, B.E. or B.Sc.
About the role
The Clinical Programmer (SDTM) is primarily responsible for SDTM programming based on Clinical Protocols, eCRF and Statistical Analysis Plans. The Clinical Programmer (SDTM) may also be responsible for data submission packages to clients and regulators.
What you'll do
- SDTM Programming and annotation of SDTM CRF
- Program and validate data sets from raw data to SDTM data
- SDTM Quality Control, Double Programming and Peer Review
- Develop Define.xml datasets, Reviewers Guides, and related regulatory documents required for submission
- Adhere to company statistical programming standards, conventions, and data standards
What you need
- SAS
- Clinical research
- Pharmacovigilance
- CRO
- R
- Quality control