Venkat K. Email & Phone Number

United States

Responsibilities:• Supported multiple Adhoc requests under tight timelines.• Have been involved in development and validation of tables, figures, and listings.• Worked in PKPD studies and had good understanding about PKPD studies.• Worked on critical SDTM, ADaM datasets and effectively handled data issues.• Experience in data validation.• Worked in R programming.• Created CRF annotations for SDTM.• Creating Analysis data sets for safety and efficacy analyses.• Preparing SAS xpt files and documentation for FDA submission.• Data conversion, data manipulation, creating Tables, Listings and Figures.• Creating SDTM mapping specifications, datasets and involved in validation.• Created and reviewed ADaM dataset specifications as per ADaM IG and Internal guidelines.• Performing Quality Check (QC) procedures by reviewing, validating, and testing work performed by others using parallel programming techniques.• Validated SDTM and ADaM datasets using P21 for checking compliance against respective IGs.• Reviewed and created information which goes into Define.xml.• Worked on Define.xml and SDRG for different client's FDA submissions.• Worked on Define.xml and ADRG for different client's FDA submissions.• Designed the SDTM specification as per the CDISC SDTM IG and ensured they meet downstream ADaM and Reporting requirements.• Good understanding of RECIST criteria for Oncology studies.

United States

Responsibilities:• Developed and implemented SAS programs and several study specific macros, to produce Tables and Graphs• Expertise in writing ADaM specifications• Managed and lead assignments and programming personnel on multiple projects.• Good understanding of Protocol, CRF and SAP• Involved in CRF Annotation of complicated studies.• Worked on Trial Design Model (TDM) datasets.• Worked in Tables, Figures and Listing .• Creation of SDTM datasets according to CDISC standards.• Support and identify areas for automation & innovation as process enhancements to improve quality of work and efficiencies.• Compared multiple database structures and re-formatted datasets to ensure consistency of variable names and formats across multiple protocols.• Created RTF and PDF outputs for reports using SAS ODS.• Involved in developing SAS Programs for the production and QC of analysis datasets, TFLs including Patient Profile.• Generated (adverse events, Treatment emergent adverse events, Demographics, Vital Signs and Laboratory Findings) and efficacy tables.• Create datasets according to CDISC SDTM following the annotated CRFs and specifications provided by the Lead programmer.• Generated rtf and pdf outputs for clinical study reports and integrated summaries for regulatory submissions.• Worked in PKPD studies and had good understanding about PKPD studies.• Generated Descriptive and Statistical summary outputs using Proc Means, Proc Freq, and Proc Univariate and Proc Summary etc.• Worked on creating Tables, Listings and Figures, data extraction, cleaning, validation, and documentation of SAS codes.• Joined as Statistical Programmer converted as Sr. Statistical Programmer.• Extensive use of procedures like PROC GCHART, PROC GPLOT to create graphs and validate them.• Hands on experience in proc template to create multiple graphs.

United States

Responsibilities:• Worked in Phase II and III of various clinical trial data in developing datasets and reports in the standard formats.• Followed CDISC standards to develop mapping specifications and create SDTM domains from raw datasets.• Prepared standard datasets from raw data set files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, Formats, and Functions.• Extensively used BASE/SAS, SAS/STAT, MACROS and SAS/GRAPH to generate safety reports of experimental drugs.• Converting raw data into SAS standard datasets and into SAS transport files as per CDISC guidelines.• Reviewed and provided inputs to CRF’s, statistical analysis plans and analysis datasets.• Performed Data Validation and Data Cleaning on raw data files provided by data management and reported them to resolve.• Started as Statistical programmer and promoted as Sr. statistical Programmer.• Attend data review meetings along with statisticians, data management team to discuss the issues while working on analysis datasets and reports.