Sowmya K.

WORK HISTORY

EDUCATION

ABOUT SOWMYA K.

With over 8 years of experience as a clinical statistical programmer and a certified Base SAS Programmer, I specialize in the analysis and reporting of clinical trials data for the pharmaceutical and contract research organization (CRO) industries. My expertise includes ensuring compliance with CDISC standards such as SDTM and ADaM, as well as a thorough understanding of regulatory frameworks including ICH-GCP, GPP, and 21-CFR Part 11.I am proficient in various SAS modules, including Base & Advanced SAS, SAS/Macros, and SAS/SQL. I excel in data manipulation and generating reports in RTF and PDF formats using the SAS ODS facility. Additionally, I have extensive experience generating Define.XML and producing SDTM-IG-compliant datasets, as well as Standardized Data Reviewer’s Guides (SDRG) and Analysis Data Reviewer’s Guides (ADRG) for comprehensive regulatory submissions. My background includes working with Efficacy, Oncology, and Pharmacokinetic (PK) Data Analysis.I have collaborated closely with multidisciplinary teams, including Data Management and Statisticians, and have overseen the work of CROs and Functional Service Providers (FSPs) as a lead programmer. My meticulous attention to detail and commitment to excellence ensure adherence to project timelines while delivering superior results. Effective communication skills complement my ability to work independently and within teams, consistently contributing to the success of clinical trial projects.