Experience

Pacira BioSciences, Inc.

• United States
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Sr SAS Programming

  • Sep 2022 - Present

  • Supported and handled longitudinal, large-scale Registry data collected by the electronic data capture databases (eg. REDCap). • Performed statistical programming and analysis on RWE and clinical trial outcome studies. • Assist in developing statistical analysis plans and statistical outputs to support core business strategy development and external communications via publications in conferences (abstracts, posters) and clinical journals (original, review manuscripts). • Proficiency to apply various statistical methods to RW research and clinical trial studies. • Established strong knowledge of RWE databases (healthcare claims, charge data master, Medicare, EMR) and clinical trial data. • Joggle multiple projects to meet the timeline. • Understand subject matters and new statistical methods. • Created and implement the development of macro/library codes (eg, SAS macros). • Support input and contribute to the development of the SAS/SQL programming environment. Show less



BioXcel Therapeutics, Inc.

• United States
• Biotechnology
• 100 - 200 Employee

• Senior SAS Programmer

  • Apr 2019 - Sep 2022

  • Designed and validated primary SDTM domains like DM, DS, EX, AE, TU, TR, RS, • Created and validated ADaM datasets like ADSL, ADAE, ADRS, and TFLs for oncology studies • Worked on oncology endpoints like PFS, OS, BOR, etc. • Developing Oncology domains- Tumor Identification TU, Tumor Results TR, and Disease Response RS. • Created SAS transport/ xpt files for electronic submission, review of define.xml, aCRF etc. • Produced Statistics in the form of summary tables, and graphs like KM Plot. • Designed customized reports with tables, and listings by PROC REPORT • Delivered suggestions on Statistical Analysis Plan SAP and worked with data management group for Case Report Form design and specifications. • Worked on ISS, and ISE by pooling various studies • Worked on reviewing specifications and mock shells • Executed efficacy analysis and created clinical trial tables for the primary and secondary endpoint as per SAP, CRF, and protocols. • Understanding of Clinical Trials (Phases I-IV), safety inspections, adverse event report reviews, and integrated safety and efficacy summary (ISS & ISE) for FDA submission. • Extensive understanding of creating SAS programs using SAS macro variables and successfully expanded the portability and consistency of existing programs. Show less



Medelis, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• SAS Programmer

  • Jul 2016 - Mar 2019

  • Created and validated major SDTM domains, ADaM datasets, and TFLs • Prepared efficacy plots like Series, Scatter, Kaplan-Meier Plot etc. • Generated efficacy tables like PFS table, OS, tables, change from baseline etc. • Generated SDTM specification as per study requirements • Applied in writing the SAS code to support the process of Quality control by enforcing various statistical procedures like Proc Freq, Proc Means, and Proc Univariate. • Developed and maintained a local macro list for SDTM and ADaM programming to derive dates, study day, visit, unscheduled visit, epoch, baseline flag, sequence number, and create supp-domain. • Worked on Pinnacle 21 for compliance check and reviewers guide • Reviewed define.xml, aCRF etc. • Involved in ISS and ad-hoc requests • Proficiency in developing Case Report Tabulation CRTs using CDISC standards and experience in reviewing define.xml • Using RECIST 1.1, created ADRS for BOR, ORR endpoints Show less