Vamsidhar Kota

About Vamsidhar Kota

A Certified SAS Programmer having experience working with SAS and SAS tools emphasizing on analysis, design, developing, testing and implementation of various projects for pharmaceutical, biotech industries.• Good experience in BASE SAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS MACROS, SAS/ACCESS, SAS PC (V8, V9), SAS ODS in Windows and UNIX environments.• Experience working in different therapeutic areas such as Urology, Orthopedic and Neurology (Multiple Sclerosis).• Mapped Raw data sets into CDISC 3.1.2 data sets and created Analysis data sets in ADaM format. • Knowledge of the drug development process with strong experience of analyzing and reporting Phase I, II, and of clinical trial data.• Experienced in Base SAS procedures such as Proc Freq, Means, Summary, Univariate, Format, Import, Export, Report, Tabulate, Transpose, Datasets, Copy and Print.• Knowledge in preparing Integrated Summaries of Efficacy (ISE) and Safety (ISS) reports for NDA Submissions.• Good working knowledge of clinical trials data like Demographic(DM), Adverse Events (AE), Disposition, Concomitant Medications(CM), Laboratory Data (LAB), ECG and vital signs.• Involved in creation of Data Definition Tables (DDT) & SAS Export files (.xpt) for FDA submission• Validation of datasets and TLGs by individual programming, peer reviewing of the fellow programmer’s code.• Proficient in using SAS ODS to produce reports in PDF, HTML, RTF formats for presentation and further analysis.• Worked with statisticians and clinical data managers to provide SAS programming in analyzing the data, generating reports, and created tables, listings and graphs as per SAP.• Exceptional problem solving skills for delivering useful and prudent solutions. A quick learner with an eye for detail and excellent analytical and quantitative skills.• Excellent written and communication skills, self-starter and a good team player.

Experience

1. Senior Principal Analyst, Statistical Programming

   Biogen

   Oct 2022 — Present · Cambridge, MA, US