Description
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. The Clinical Programmer (SDTM) works collaboratively with the project biostatisticians, Statistical Programmers and other project stakeholders to produce quality SDTM outputs based on the eCRF design, clinical protocol and Statistical Analysis Plan.

Responsibilities:
- 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.
- Ensure that SAS programs are properly documented and traceable.
- SAS data set validation by using pinnacle 21.
- Maintain study documentation, programs and files within project files.




- Maintain timesheets.
- Participate in department meetings

Experience and Qualifications:
Education:
- Bachelor’s Degree in Life Sciences, Computer Science, Mathematics, Statistics, or Quantitative/Analytical fields.
- SDTM Programming
- Clinical Protocols and Statistical Analysis Plans
- Organizational Skills

Experiences:
- Experience in Pharmaceutical industry, CRO or related experience.
- 6 months –2 years of programming experience specifically in SDTM concepts.
- Proficiency in SAS: SAS is widely used for SDTM dataset creation and validation
- Knowledge of CDISC standards: Understanding SDTM, SDTMIG, and controlled terminology is essential
- Programming in R: Tools like allow SDTM dataset creation in R, offering modular and reusable algorithms for automation
- Attention to detail: Ensuring data integrity and compliance with regulatory requirements.
- Clinical trial knowledge: Fam

📌 Clinical Data Programmer I (India)
🏢 Novotech
📍 India