KUNAL MAKWANA

HIGHLIGHTS

* ***** ** *** ***********

experience

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Advanced Microsoft Excel and Access

skills

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SAS 9.4, SAS Studio, SAS EG, R, SPSS

knowledge.

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Statistical analysis and database

knowledge

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• Excellent communication skills

LINKEDIN URL

www.linkedin.com/in/kunal-m-20883513

AREA OF EXPERTISE

• Statistical Program Management

• Project & Time Management

• Customer Service & Satisfaction

• Regulatory Compliance

• Cross-Functional Collaboration

THERAPEUTIC AREAS

• Cardio Vascular Study

• Diabetes Study

• Oncology (Solid Tumors)

• Vaccine Study

SAS programmer in pharmaceutical industry since 2014. Experience analyzing data and producing tables listings as well as figures for Safety, Efficacy and PK/PP datasets.

Experienced in creating and reviewing of components for Electronic submission Package .

EDUCATION

Base SAS Certification

SAS Institute

Ph.D. Pharmaceutical Sciences

Singhania University, Rajasthan, India.

EXPERIENCE

July 2021 - Current

Statistical Programmer Pfizer, Through Eliassen Group Inc, Edison, NJ October 2019 - June 2021

Consultant Senior Statistical Programmer Celgene Pharmaceuticals, Berkeley Heights, NJ

Performed analyses of clinical trials for treatment related to vaccine therapy, diabetes and solid tumors.

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• 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).

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Produced Esub package components like data reviewer's guide, aCRF, define.XML for Regulatory submissions.

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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.

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• 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.

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· 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.

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Created Integrated Summary Of Safety and Efficacy at both ADAM and SDTM level.

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CONTACT

Edison, New Jersey 08820

+1-732-***-****

ad2dol@r.postjobfree.com

Bold Profile

August 2018 - September 2019

Senior SAS Programmer Novartis, (Through Navitas, Princeton, NJ), East Hanover

September 2017 - August 2018

Statistical Programmer III Prometrika, Boston, MA

March 2017 - August 2017

Clinical SAS Programmer Immunomedics, Morristown, NJ October 2015 - February 2017

Statistical Programmer Lambda Clinical Research, Ahmedabad, Gujarat, India

February 2014 - October 2015

Clinical SAS Programmer Cliantha Research, Ahmedabad, Gujarat Acted as lead programmer producing tables, listings, and analysis datasets for oncology clinical study.

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• Used SAS and CDISC knowledge to map legacy datasets.

• Reviewed results of SAS programming.

• Worked with SAS programmers to QC various outputs..

• 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.

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Performed quality control programming based on the SAP to verify analysis populations and related endpoints.

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• 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.

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• 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.

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Performed programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format.

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· Worked on edit checks programming for various domains related to study.

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Implementing CDISC standards to clinical trial data through converting raw datasets to SDTM datasets with reference of mapping documents prepared by following SDTMIG.

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• Generate reports either in HTML, PDF or RTF formats. Worked closely with Data Management teams in the process of generating edit check programming and also quality listing outputs.

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Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/Base and SAS/Macro facility.

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Worked on third part data programming data activities like Lab reconciliation, adverse event reconciliation as well Pk reconciliation.

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