Kunal Makwana
Edison,New Jersey
Summary
SAS programmer in pharmaceutical industry since 2015.
Experience analyzing data and producing tables for both safety and efficacy datasets.
Experienced in creating and reviewing of components for Esubmission Package .
Overview
10
10
years of professional experience
Work History
Statistical Programmer
Pfizer, Through Eliassen Group Inc
07.2021 - Current
- Performed analyses of clinical trials for treatment for vaccine therapy , diabetes and solid tumors.
- Produced tables and listings of safety and efficacy results.
- Produced monthly reports of safety for ongoing trials.
- Mapped clinical trial datasets to comply with CDISC Study Data Tabulation Model (SDTM) standards. (Produced specifications, transformed data in SAS, produced datasets for internal review and adjusted programs based on comments received, and validated datasets).
- Produced Esub package components like data reviewer's guide, aCRF, define.XML for Regulatory submissions.
Consultant Senior Statistical Programmer
Celgene Pharmaceuticals
10.2019 - 07.2021
- Build programs to create SAS datasets from the clinical database, external vendor data sources, and other sources while following the clinical study's protocol or statistical plans.
- Cooperated with other programmers to validate tables and datasets.
- Reviewed dataset specifications for consistency with CDISC SDTM.
- Created macros to do complex manipulations and analysis of PK datasets.
- · Supported Clinical Data Management task like SAE as well as Lab Reconciliation, designing eCRF, creating edit checks, User Acceptance Testing (UAT), Data Cleaning and Query process.
Senior SAS Programmer
Novartis, (Through Navitas, Princeton, NJ)
08.2018 - 09.2019
- Acted as lead programmer producing tables, listings, and analysis datasets for oncology clinical study.
- Used SAS and CDISC knowledge to map legacy datasets.
- Reviewed results of SAS programming.
- Worked with SAS programmers to QC various outputs..
Statistical Programmer III
Prometrika
09.2017 - 08.2018
- Provided statistical and SAS programming support for clinical trials.
- Combined data from multiple studies.
- Wrote SDTM and Analysis Data Model (ADaM) specifications as per statistical analysis plans (SAPs), and mock tables, figures, and listings.
- Performed quality control programming based on the SAP to verify analysis populations and related endpoints.
- Communicated with outside contract programmer to validate results.
- Provided further analysis as requested by FDA after submission.
- Carried out new analyses on past studies and designed tables to display information.
Clinical SAS Programmer
Immunomedics
03.2017 - 08.2017
- Produced patient profiles listings for oncology studies.
- Created standard and custom reports to be used by the Clinical Data Managers in their data review and cleaning efforts.
- Performed programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format.
- · Worked on edit checks programming for various domains related to study.
Statistical Programmer
Lambda Clinical Research
10.2015 - 02.2017
- Implementing CDISC standards to clinical trial data through converting raw datasets to SDTM datasets with reference of mapping documents prepared by following SDTMIG.
- Generate reports either in HTML, PDF or RTF formats.
Clinical SAS Programmer
Cliantha Research
02.2014 - 10.2015
- Worked closely with Data Management teams in the process of generating edit check programming and also quality listing outputs.
- Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/Base and SAS/Macro facility.
- Worked on third part data programming data activities like Lab reconciliation , adverse event reconciliation as well Pk reconciliation.
Education
SAS Certification -
Ph.D. - Pharmaceutical Sciences
Singhania University, Rajasthan, India.
Rajasthan, India.Skills
- 6 years of SAS programming experience
- Advanced Microsoft Excel and Access skills
- R, SPSS knowledge
- Statistical analysis and database knowledge
- Excellent communication skills
Linkedin URL
www.linkedin.com/in/kunal-m-20883513
Timeline
Statistical Programmer
Pfizer, Through Eliassen Group Inc
07.2021 - Current
Consultant Senior Statistical Programmer
Celgene Pharmaceuticals
10.2019 - 07.2021
Senior SAS Programmer
Novartis, (Through Navitas, Princeton, NJ)
08.2018 - 09.2019
Statistical Programmer III
Prometrika
09.2017 - 08.2018
Clinical SAS Programmer
Immunomedics
03.2017 - 08.2017
Statistical Programmer
Lambda Clinical Research
10.2015 - 02.2017
Clinical SAS Programmer
Cliantha Research
02.2014 - 10.2015
SAS Certification -
Ph.D. - Pharmaceutical Sciences
Singhania University, Rajasthan, India.