Zayan Qureshi

• Served as Principal Programmer for a Phase 3 immunology study ensuring FDA compliance via P21.

• Developed ADaM datasets (ADSL, BDS, OCCDS) and created efficacy and safety TLFs.

• Designed metadata and advanced visualizations including KM, Forest, Swimmer, and Waterfall plots.

• Supported PK/PD dataset creation and regulatory compliance (21 CFR Part 11) processes.

TECHNOLOGIES

SAS (Base, Advanced, Macros), SQL, R (Beginner),CDISC, SDTM, ADaM,SAS, R, P21 Validator, Clinical Data Repositories,GCP, GPP, 21 CFR Part 11

• Led programming for Phase 2/3 clinical studies; prepared metadata, mock shells, and DSUR reports.

• Managed vendor deliverables, mentored junior programmers, and supported FDA submissions.

• Built macros for process optimization and handled ML datasets for regulatory requests.

• Served as POC for statistical programming at the India site, ensuring P21 compliance.

TECHNOLOGIES

SAS (Base, Advanced, Macros), SQL, R (Beginner),CDISC, SDTM, ADaM,SAS, R, P21 Validator, Clinical Data Repositories,GCP, GPP, 21 CFR Part 11

• Transformed raw data into SDTM and ADaM datasets using SAS Base/Macros.

• Created SDTM specifications, conducted quality checks, and generated mock TLFs.

• Worked on oncology endpoints such as PFS, OS, ORR, and DFS along with efficacy datasets (ADLB, ADTR, ADTTE).

• Championed data quality initiatives and standard implementation.

TECHNOLOGIES

SAS (Base, Advanced, Macros), SQL, R (Beginner),CDISC, SDTM, ADaM,SAS, R, P21 Validator, Clinical Data Repositories,GCP, GPP, 21 CFR Part 11

• Delivered sponsor-specific data transformations for leading US pharmaceutical clients.

• Developed SAS macros and programs for data mapping, analysis, and automation.

TECHNOLOGIES

SAS (Base, Advanced, Macros), SQL, R (Beginner),CDISC, SDTM, ADaM,SAS, R, P21 Validator, Clinical Data Repositories,GCP, GPP, 21 CFR Part 11