Usha Ch

To obtain a position that will enable to keep up with technology edge and succeed in an environment of growth and excellence. Having 1+ year experience as a Clinical Statistical Programmer with experience working on Phase I-IV clinical trials. Datasets were developed, validated, and maintained in accordance with CDISC and non-CDISC standards. Creating SDTM domains in the SAS/Windows environment utilizing the SDTM Mapping standard and SAS Programming.

Data Programmer - Scientist - Certara Netherlands B.V.

(2022-01 - 2023-02)

• SDTM domains are validated using the Pinnacle 21 tool, and all pinnacle report issues are resolved.
• PK/PD Statistical Programmer experience working on Phase I-IV clinical trials
• Experience in submission package for ADPC/PP/ADPP which includes DPS, define files, ADRG, SDRG and pinnacle reports
• Involved in ad-hoc requests for data transfers as directed by the customer and internal team communication. Other duties as given by the lead programmers
• Actively involved in creation of SDTM/ADaM datasets.
• Participated in multiple projects for construction of ADPC, PP and ADPP
• Experience in creating define files, SDRG, ADRG and pinnacle validation report
• Participated in implementation guide review for popPK dataset (ADPPK)

Master of Science - Organic Chemistry - Osmania University, Hyderabad, India

Bachelor of Science - Maths, Physics & Chemistry - Kakatiya University, Jangaon, India