Vishal Kunden
Edison,New Jersey
Summary
Highly skilled and detail-oriented Clinical SAS Programmer with 14 years of progressive experience in the pharmaceutical and CRO industries. Extensive expertise in clinical trial data analysis, SDTM and ADaM dataset development, TLF (Tables, Listings, and Figures) generation, and CDISC compliance. Proven ability to collaborate with cross-functional teams including statisticians, data managers, and regulatory affairs. Proficient in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph across multiple therapeutic areas including oncology, cardiology, and immunology. Strong knowledge of regulatory submission standards (e.g., FDA, PMDA) and experience supporting eCTD submissions. Adept at problem-solving, process optimization, and mentoring junior programmers.
Overview
15
15
years of professional experience
Work History
Principal Statistical Programmer
Karyopharm Therapeutics
Newton, MA
04.2024 - Current
- Review and understand study documents, including Protocol, Electronic case report forms(eCRFs) and Statistical Analysis plan.
- Reviewing and understands raw eDTC database structure.
- Participating in Statistical Analysis Plan reviewing and provide comments to statistician.
- Major contribution to the development of Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) dataset specifications.
- Develop programs for most complex graphs, Kaplan meier graphs for PFS, OS, TTE, Waterfall plots for Best overall responses, Forest Plot for OS & PFS.
- Develops global standard macros to improve efficiency of the statistical programming group.
- Develop & Maintain programs to generate SDTM & ADaM Datasets and TFL’s.
- Develop Ad Hoc reports as per request by Statistician and Clinical team which required by FDA.
Principal Statistical Programmer
Novartis Healthcare
07.2017 - 04.2024
- Handled team and projects in clinical trials from Statistical programming line function as Lead.
- Worked on clinical trials of Phase I-III data like RECIST, iRECIST, Biomarker, demographic, Pharmacokinetics, adverse event, serious adverse events, laboratory, ECG and vital signs etc.
- Developed and Validated of SDTM and ADaM datasets & Specification as per CDISC standards.
- Subject Matter Expert in Response Evaluation Criteria in Solid Tumor & Immuno therapy (RECIST & iRECIST).
- Worked on complex Analysis Datasets like Adrecist, Adlb, Adex, adexsum, Pk merge datasets etc.
- Developed and validated TFL’s includes Safety, Efficacy, Pk parameter outputs.
- Produced Kaplan-meier plots using proc lifetest procedures based on oncology endpoints like PFS, OS, TTE etc.
- Extensively developed MACROS for several statistical analysis and maintained existing ones.
Senior Statistical Programmer
Quartesian Data Company
03.2016 - 07.2017
- Reads Protocol and Statistical Analysis Plan (SAP) to understand study design and study details.
- Developed & Validated TFLs in accordance with client approved TFL document.
- Developed & Validated SDTM & ADAM datasets as per CDISC standard as well as Client specific implementation standards.
- Collaboration with Clinical Trial Team, which includes Clinical Trial Leader, Senior Statisticians, Medical Writers, and Project Managers to assure programming needs are met, effectively organized and managed multiple assignments with challenging timelines.
- Extensively developed MACROS for several statistical analysis and maintained existing ones.
Statistical programmer 1
Quintiles Technologies India Pvt. Ltd.
01.2015 - 02.2016
- Developed programs for generating dataset, summary tables and Listings.
- Responsible for creating data sets for analysis and validation as per the regulatory requirements.
- Created macros and stored processes for automating the report generation process.
- Worked with statistician for a project to define the analysis datasets and analysis programs required.
- Validate Analysis datasets, tables and listing through parallel programming.
Statistical programmer (Level F)
Accenture Services Pvt. Ltd.
01.2013 - 12.2014
- Developed & Maintained standard macros for Tables Listings Figures.
- Developed Programs for SDTM plus dataset and Adam datasets in accordance with approved client specifications.
- Reading Protocol and Statistical Analysis Plan (SAP) to understand study design and study details.
- Use standard programs to generate tables, listings, Figures.
Analyst SAS programmer
Cognizant Technology solutions Pvt. Ltd.
Mumbai
02.2011 - 01.2013
- Create datasets, tables and listings, in accordance with approved client specifications for clinical studies.
- Reading Protocol and Statistical Analysis Plan (SAP) to understand study design and study details.
- Validated Dataset, tables by using parallel programming.
- Extensively developed MACROS for several statistical analysis and maintained existing ones.
Education
Post Graduate Diploma in Business Administration - Operations
Maharashtra Institute of Technology
Pune12.2012
Bachelor of Commerce -
BNN college
Mumbai03.2003
Some College (No Degree) - SAS Certified Base Programmer for SAS 9
SAS Institution
MumbaiSkills
- Microsoft Windows
- SAS EG
- BASE
- MACRO
- ODS
- SQL
- REPORT
- SAS 92
- R Basics
Timeline
Principal Statistical Programmer
Karyopharm Therapeutics
04.2024 - Current
Principal Statistical Programmer
Novartis Healthcare
07.2017 - 04.2024
Senior Statistical Programmer
Quartesian Data Company
03.2016 - 07.2017
Statistical programmer 1
Quintiles Technologies India Pvt. Ltd.
01.2015 - 02.2016
Statistical programmer (Level F)
Accenture Services Pvt. Ltd.
01.2013 - 12.2014
Analyst SAS programmer
Cognizant Technology solutions Pvt. Ltd.
02.2011 - 01.2013
Post Graduate Diploma in Business Administration - Operations
Maharashtra Institute of Technology
Bachelor of Commerce -
BNN college
Some College (No Degree) - SAS Certified Base Programmer for SAS 9
SAS Institution
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