Saie Sardesai

• Participate in projects dealing with assessment, design and/or implementation of data standards (e.g., CDISC SDTM).
• Annotate case report forms (CRFs) according to the CDISC Implementation Guideline for migration to SDTM.
• Create SDTM specifications document based on CDISC Implementation Guideline.
• Follow standardized SDTM migration programming procedures to create quality Standard Data Tabulation Model (SDTM) compliant SAS datasets and Define.XML documents
• Create analysis datasets (e.g., ADAM) specifications based on Statistical Analysis Plan (SAP) or any study analysis algorithm.
• Convert analysis datasets specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.
• Write and maintain documentation of changes to SAS code, programs, and specifications.
• Analyze and Revise SAS programs for corrections, enhancements, or system environment changes.
• Modify and maintain SAS programs written by others.
• QC SAS programs for Dataset, Tables, Listings, and Figures following the departmental QC procedures.
• Successfully contributed in leading teams managing multiple projects simultaneously while mentoring junior programmers to enhance their skills and productivity.
• Assist in establishing standardized programming procedures and work instructions; develop, enhance, evaluate, and validate standardized macros and utility programs; ensure that regulatory requirements are met through validation/compliance activities.
• Prepared a variety of different written communications, reports and documents to ensure smooth operations
• Validated SDTM/ADaM using Pinnacle 21
• Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork
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Senior Programmer (08/2017-08/2021) ,GSK India

• Elected as a global lead for an early phase study, orchestrated teams across functionalities to work around high quality submission in spite of accelerated timelines and potential data quality risks.
• Appointed as India SPOC for multiple studies where I was involved in mentoring less experienced teammates while providing individual contribution > 50% of FTE in study tasks for effective submissions.
• Closely collaborated with micro and clinical team for automating monthly drug response trend analysis for an oversight submission project.
• Created SAS programs following specifications to generate analysis datasets, statistical reports/listings, tables and figures while abiding with ICH and GxP guidelines as part of US & European drug regulatory submissions .
• Worked on safety & efficacy analysis domains in both CDISC and IDSL study types for different clinical phases including IDMC submissions and regulatory submissions.
• Established intermediate level expertise on GSK in house tools (HARP)- focusing on usage of standard established macros across different study submissions.
• Adhered to GSK Quality check SOP's, GxP & ICH guidelines along with usage of GSK in house tools (QUIT) while performing validation checks to eliminate any possible errors and improved functionality.
• Collaborated with statisticians, data management, CPMS, clinicians and programming stakeholders to establish clear communications within teams regarding programming inputs, issues raised/ general progress updates.
• Drove team meetings for strategic implementations of SOP's and in- house tools for study benefits.
• Nominated as R trainer to provide trainings to colleagues in Biostats India workspace.