Mayuri Patel

Clinical Statistical Programmer with experience supporting Phase I and Phase II clinical trials within CRO and pharmaceutical environments. Skilled in development, validation, and quality control of CDISC-compliant SDTM and ADaM datasets, annotated Case Report Forms (aCRFs), define.xml documentation, and Tables, Listings, and Figures (TLFs) using SAS programming. Experienced in statistical programming workflows including dataset derivations, QC validation, Pinnacle 21 validation, SAP interpretation, clinical data cleaning support, and reproducible programming practices.

Strong knowledge of CDISC standards, ICH-GCP guidelines, FDA and Health Canada regulations, and Good Programming Practices (GPP). Proficient in SAS, PROC SQL, SAS Macros, clinical trial data review, and regulatory-compliant documentation.

Clinical SAS Programmer - Self-Employed / Training Project - Toronto, Ontario, Canada

(2024-01 - 2026-12)

Phase I Oncology Clinical Trial – Intralesional Immunotherapy in Advanced Merkel Cell Carcinoma

• Developed SAS programs for SDTM and ADaM dataset creation including ADSL, ADAE, and ADLB datasets.
• Performed dataset mapping, derivations, and validation activities according to CDISC SDTM and ADaM standards.
• Developed and validated Tables, Listings, and Figures (TLFs) based on SAP specifications and mock TLF shells.
• Performed QC programming validation and output verification to ensure reproducibility, traceability, and accuracy.
• Conducted SDTM and ADaM validation checks using Pinnacle 21 validation concepts.
• Supported define.xml documentation activities and metadata review.
• Assisted with annotated CRF (aCRF) review and dataset traceability documentation.
• Supported clinical data cleaning activities through identification and review of data discrepancies.
• Applied reusable SAS macros and standardized programming practices to improve efficiency and consistency.
• Worked with clinical trial workflows including derivations, analysis-ready datasets, and reporting activities.
• Gained practical exposure to reviewer guide support activities including cSDRG and ADRG concepts.

Junior SAS Programmer - IQVIA - India

(2014-06 - 2016-05)

• Assisted in development and validation of CDISC-compliant SDTM and ADaM datasets for Phase I and Phase II clinical studies.
• Developed SAS programs for creation of analysis-ready datasets based on protocols, SAPs, and TLF shells.
• Generated Tables, Listings, and Figures (TLFs) using PROC REPORT, PROC FREQ, PROC MEANS, and PROC SQL.
• Performed QC validation and output verification to ensure accuracy, consistency, and reproducibility of deliverables.
• Supported clinical data cleaning activities by identifying data discrepancies and reviewing clinical datasets.
• Assisted with annotated CRF review, metadata review, and traceability documentation activities.
• Supported define.xml documentation and validation-related activities.
• Applied reusable SAS macros and standardized programming practices to improve programming efficiency.
• Collaborated with statisticians, data management teams, and cross-functional study teams for interim analyses and clinical reporting activities.
• Ensured compliance with CDISC standards, FDA guidelines, ICH-GCP requirements, and Good Programming Practices (GPP).

QC Technician - Centre for Probe Development and Commercialization - Toronto, ON

(2018-01 - 2022-09)

• Conducted quality control analysis within GMP-regulated pharmaceutical laboratory environments.
• Maintained validation documentation, audit-ready records, and compliance documentation.
• Supported data integrity review, deviation investigations, and CAPA documentation activities.
• Collaborated with QA and regulatory teams to support compliance with Health Canada and FDA requirements.

Packaging Technician - Apotex - Toronto, ON

(2016-12 - 2017-12)

• Performed pharmaceutical packaging operations in compliance with cGMP and SOP requirements.
• Maintained production documentation and quality records supporting regulatory compliance and audit readiness.
• Collaborated with QA and production teams to resolve documentation discrepancies.

QC Officer - Sun Pharmaceutical Industries - India

(2012-08 - 2014-05)

• Performed laboratory quality analysis for raw materials, finished products, and stability samples.
• Maintained analytical records and regulatory documentation according to SOP and GMP guidelines.
• Supported quality audits, compliance activities, and laboratory investigations.

MBA - Total Quality Management (2013 - 2013)

Bachelor of Pharmacy (2010 - 2010)