Vishnu Vardhan Kambala
Senior Manager
Bangalore
Summary
- SAS Analytic professional with 14 years of experience in Statistical programming in clinical trials.
- Expertise in SAS/BASE, SAS Macro and SAS SQL.
- Developed Safety and Efficacy ADaM’s and TLF’s.
- Involved in Project Management discussions.
- Worked on Pinnacle 21 Enterprise on both SDTM and ADaM
- Worked on submission packages to PMDA Regulatory authorities.
- Effective Collaboration with Clinical Trial Team (CTT) in regard with the study activities.
Overview
14
14
years of professional experience
Work History
Senior Manager
TCS
09.2022 - Current
- Supported Vaccines Portfolio
- Currently working as Team Lead for Oncology studies
- RECIST 1.1 and Lugano 2014
- Time to Event Analysis
Principal Statistical Programmer
Novartis
11.2016 - 09.2022
- Lead the project as a Trial Programmer for Oncology therapeutic area studies
- Submission deliverables on CRT package aCRF, define.xml, SAS pointers and ARM document for PMDA
- Supported for FDA and EMEA Inspection readiness
- Interact with the stakeholders in regard with the deliverables and timelines
- Collaborating with other line functions discussing the project overflow
- Knowledge on global metadata and corresponding dictionaries
- Preparation and Validation of analysis datasets
- Discussion on CAPA with Quality assurance team
- Worked as an independent programmer for blinded studies for DMC activity
- Created study level utility macro for assigning metadata for the variables in ADaM’s, and to create XPT files for Pinnacle 21
Senior Statistical Programmer I
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01.2016 - 11.2016
- Developing tables, listings, and graphs for Vertex pharmaceuticals
- Supported ADaM work for Celgene
- Performed data visualization for mean dose, bar charts etc
Statistical Programmer I
Quintiles (IQVIA)
02.2013 - 01.2016
- Developed ADaM domains on SAS DI studio for Eli Lilly Pharmaceuticals
- Generating the datasets for analysis purpose by converting raw data into prescribed format
- Reviewed the production program logs for errors, warnings, or other notes that which would affect the quality of the deliverable
Statistical Programmer I
InVentiv International Pharma Services (Syneos)
09.2011 - 01.2013
- Have delivered Trial Level Safety Review (TLSR), and Development Safety update Report (DSUR) for the client Eli Lilly
- Developed the patient profiles reports
SAS Programmer Trainee
Ephicacy Life science Analytics
01.2011 - 08.2011
- Worked on pilot study to have an overview of data management
Skills
- Base SAS Certified
- SAS Macros and SAS SQL
- Safety and Efficacy ADaM's and TLF's
- Oncology Solid Tumors
- RECIST 11 and Lugano 2014
- Pinnacle 21 Enterprise
- Project Management
- Cross-functional Collaboration
- CRT package (definexml, SDRG and ADRG) for PMDA submission
Timeline
Senior Manager
TCS
09.2022 - Current
Principal Statistical Programmer
Novartis
11.2016 - 09.2022
Senior Statistical Programmer I
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01.2016 - 11.2016
Statistical Programmer I
Quintiles (IQVIA)
02.2013 - 01.2016
Statistical Programmer I
InVentiv International Pharma Services (Syneos)
09.2011 - 01.2013
SAS Programmer Trainee
Ephicacy Life science Analytics
01.2011 - 08.2011