Vishal Kunden
Edison,NJ
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
14
14
years of professional experience
7
7
years of post-secondary education
Work History
Principal Statistical Programmer (Contractor)
Karyopharm Therapeutics
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.
Principal Statistical Programmer
Novartis Healthcare Pvt. Ltd.
07.2017 - 04.2024
- Handled team and projects of clinical trial studies from Statistical programming line function as Lead and Accountable for programming, planning, and coordinating a portfolio of oncology studies.
- Subject Matter Expert in Response Evaluation Criteria in Solid Tumor & Immuno therapy (RECIST & iRECIST) to resolve queries of programmers.
- Worked as a Trial Programmer in the Oncology therapeutic area, managing project-level activities as the Lead Programmer, which included project management tasks.
- Worked on PKPD process, developed programs for Pk merge Dataset, ADPP, ADPC, PK parameters tables, PK Concentration summary tables, listings and Figures.
- Review Protocol, CRF, Statistical Analysis Plan, and TFL documents, providing inputs and comments from a statistical programming perspective.
- Develop programming specifications for analysis datasets, create or validate analysis datasets, and generate or validate TLFs.
- 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.
- 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.
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 analysis datasets, summary tables and Listings.
- Developed macros and maintained for automation of the report generation process.
- Worked with statistician for a project to define the analysis datasets and TFL’s.
- 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.
- Reads Protocol and Statistical Analysis Plan (SAP) to understand study design and study details.
- Used standard programs to generate tables, listings, Figures.
Analyst SAS programmer
Cognizant Technology solutions Pvt. Ltd.
02.2011 - 01.2013
- Developed & Validated SDTM plus and Analysis datasets, tables and listings, in accordance with approved client specifications for clinical studies.
- Reads Protocol and Statistical Analysis Plan (SAP) to understand study design and study details.
- Extensively developed MACROS for several statistical analysis and maintained existing ones.
Education
Post Graduate Diploma in Business Administration - Operations
Maharastra Institute of Technology University
Mumbai 09.2009 - 12.2012
Bachelor of Commerce - Accounts & Trading
B.N.N College - Mumbai University
Mumbai 06.2000 - 04.2003
SAS Certified -
SAS Certified Base Programmer For SAS 9
Mumbai 04.2011 - 02.2012
Skills
- Operating System: Microsoft Windows, SAS EG
- SAS Skills: BASE, MACRO, ODS, SQL, REPORT
- Programming Language: SAS 92, SQL, R Basics
Timeline
Principal Statistical Programmer (Contractor)
Karyopharm Therapeutics
04.2024 - Current
Principal Statistical Programmer
Novartis Healthcare Pvt. Ltd.
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
SAS Certified -
SAS Certified Base Programmer For SAS 9
04.2011 - 02.2012
Analyst SAS programmer
Cognizant Technology solutions Pvt. Ltd.
02.2011 - 01.2013
Post Graduate Diploma in Business Administration - Operations
Maharastra Institute of Technology University
09.2009 - 12.2012
Bachelor of Commerce - Accounts & Trading
B.N.N College - Mumbai University
06.2000 - 04.2003
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