Yash Koyal

About Yash Koyal

As a passionate stats programmer working in the clinical domain, I have extensive…

Experience

1. Clinical Statistical Programmer

   Saama

   Mar 2022 — Present · Pune, IN

   Transformed and manipulated raw clinical data into CDISC-compliant SDTM datasets using SAS and Python programs.Did data manipulation by using different SAS FUNCTIONS, MERGE, IF-THEN CONDITION, DO-WHILE-UNTIL loops, DATE MANIPULATION, and procedures like PROC SORT, PROC MEANS, PROC FREQ, PROC SQL, PROC REPORT, PROC COMPARE for analysis, validation and reporting.Worked on Oncology, Ophthalmology, and Nephrology therapeutic areas with detailed exposure to Infectious Diseases, Secondary Hyperparathyroidism, and Neovascular AMD raw clinical data.Analyzed through and worked on complex clinical concepts such as double-blinding of treatments, subject rescreening, and masked datasets to ensure data integrity and compliance with regulatory standards.Developed and validated complex domains such as LB, VS, OE, MB, DS, AE, and MH, handling extensive Phase raw datasets. Debugged various raw data structural and mapping complexities by understanding program logs and errors. Additionally, actively contributed to understanding and validating crucial domains like DM, SE, SV, EX, etc to ensure high-quality dataset outputs.Worked on clinical study documents such as CRF, ALS, Define.xml, Pinnacle P21 Community, and study protocols to understand study scope and accurately map raw clinical datasets to CDISC-compliant SDTM standards. Analyzed and annotated comprehensive P21 reports for a Phase study, thereby documenting the distinction between source data issues and programming updates.Along with primary roles, solely developed and maintained documentation for logic utilized in custom functions and macros implemented into studies.Functioned as a stand-in lead for a complex Phase study where my roles were to communicate with onsite POC and client stats team regarding updates for study activities, queries and timelines. Additionally to co-ordinate, delegate and manage timelines for study related tasks with the internal team.