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Trainee Statistical Programmer
December 27, 1996

About Candidate

I am Clinical SDTM Programmer typically has around 1.3 years of experience and I am responsible for transforming raw clinical trial data into the standardized CDISC SDTM format. This involves programming and validating datasets to ensure compliance with regulatory requirements and industry standards. I also collaborate with cross-functional teams, perform quality checks, and contribute to the development of programming guidelines and best practices. I am having Strong programming skills, knowledge of CDISC standards, and attention to detail.Please let me know if any opportunities are there for me.

Global Certifications (if any)

Education

M
Master's of statistics 2019
MIT WORLD PEACE UNIVERSITY PUNE

I have completed Master's in statistics.

Work & Experience

T
Trainee Statistical Programmer February 21, 2024
Clinchoice Private Limited

1. SDTM Implementation: Assist in the implementation of SDTM standards to organize and structure clinical trial data in compliance with CDISC guidelines. 2. Dataset Creation: Contribute to the creation of SDTM datasets, such as DM (Demographics), AE (Adverse Events), DS (Disposition), and others, from source data, ensuring accuracy and consistency. 3. Programming Support: Provide support to senior SDTM programmers in SAS programming tasks related to data transformation and mapping. 4. Data Validation: Conduct data validation activities to identify and resolve discrepancies in the data, ensuring high-quality SDTM deliverables. 5. Documentation: Maintain comprehensive documentation of data conversion processes and SDTM specifications. 6. Collaboration: Collaborate with cross-functional teams, including data managers, clinical programmers, and biostatisticians, to support efficient data collection and standardization. 7. QC Checks: Perform quality control checks on SDTM datasets to ensure compliance with regulatory requirements and internal data standards. 8. Regulatory Compliance: Familiarize yourself with relevant regulatory guidelines (e.g., FDA, EMA) to ensure SDTM datasets are submission-ready for regulatory approval.

Skills

Base sas certification
901%