Siva Kumar Email & Phone Number

Cambridge, Massachusetts, United States

Cambridge, Massachusetts, United States

Greater Boston Area

• Worked extensively with legacy, completed, and ongoing studies including ISS studies.• Mapping datasets from old studies to comply with new studies for the creation of ISS datasets.• Development and Validation of ISS tables and listings.• Production and validation of various analysis datasets, tables, listings and graphs (TLG's) per the SAP for NDA. • Involved in the support of Phase II, and III clinical trials and worked majorly on therapeutic areas related to Central Nervous System, Oncology and Liver disorders.• Extensively worked on Data mapping from existing Raw data to CDISC SDTM Standard and Review CRFs (Case Report Form) to ensure consistency with protocol and adequacy in collecting Data to meet objectives defined in protocol.• Assisted statisticians in generating frequency distributions and to present the results in histograms, box-plots, pie-chart and scatter-plots using the SAS graphical procedures.• Automated generation of graphical outputs for specialty lab and PK/PD data at overall and patient-level, using SAS advanced graphical procedures and ODS functionality.• Coordinated with the Data Management Lead of respective studies about various data issues and worked to resolve the queries.• Provided programming support for CSR (Clinical Study Report), IB (Investigator’s Brochure) submissions.• Involved in reviewing define.xml and preparing Study Data Reviewers guide (SDRG), Analysis Data Reviewer Guide (ADRG), creation of electronic datasets (i.e., SAS Transport Files) for FDA submission.

Master’S Degree, Information Technology, 3.86 Gpa

Graduated in Information Technology with core subjects Information Technology, System Analysis and Design, System and Networks, IT security

Masters In Pharmacy, Pharmaceutics