Principal Statistical Programmer (FSP) - Apogee Therapeutics
(2025-11)
- Support statistical programming activities for Phase II atopic dermatitis studies throughout the study lifecycle, including protocol and SAP review, interim analyses, safety reviews (IDMC and DSUR), dry runs, soft lock, database lock, unblinded deliverables, and post-database-lock analyses.
- Review and independently validate vendor programming packages using EDC and vendor source data; identify data and programming issues, recommend technical solutions, and ensure accuracy, traceability, regulatory compliance, and adherence to quality-control standards.
- Independently validate PK/PD ADaM datasets and related tables by reconciling vendor data against EDC source data; investigate discrepancies, communicate findings to Clinical Data Management and vendor programming teams, and track data and programming issues through resolution.
- Validate CDISC-compliant ADaM datasets and TLFs supporting efficacy, safety, PK/PD, and regulatory deliverables.
- Collaborate closely with Biostatistics, Clinical Development, Data Management, and external vendors to ensure accurate, timely, and high-quality programming deliverables.
Principal Statistical Programmer (Contractor) - Gilead Sciences
(2024-09 - 2025-07)
Supported statistical programming activities for a global, randomized, open-label, multicenter Phase III oncology study evaluating combination therapies in patients with unresectable or metastatic gastric cancer.
- Developed programming solutions for key efficacy analyses, including Overall Survival (OS) and Progression-Free Survival (PFS), supporting treatment comparisons in patients with high PD-L1 expression.
- Identified complex data and programming issues through custom edit-check programs and comprehensive reviews of aCRFs, CDISC implementation, table shells, and programming outputs; collaborated with study teams to investigate discrepancies and implement practical solutions.
- Designed reusable utility macros and centralized programming frameworks to standardize TFL development, including approximately 80 TEAE summary tables and 12 AE listings. Improved programming efficiency, consistency, maintainability, and compliance across study deliverables.
- Served as a technical resource for programming-related questions, sharing best practices, troubleshooting complex SAS programming issues, and recommending optimal implementation approaches for study-specific requirements.
Principal Statistical Programmer (Contractor) - Eli Lilly Inc.
(2022-02 - 2024-04)
Supported statistical programming activities for a global, randomized, double-blind, placebo-controlled Phase III heart failure study.
- Led development of approximately 20 Win Ratio analysis tables for the Primary Hierarchical Composite Endpoint and developed graphical outputs to visualize Win, Loss, and Tie rates, utilizing SAS macro programming to automate production and improve efficiency.
- Provided technical guidance to programmers in resolving complex programming issues and clarifying study endpoint derivation rules. Explained the rationale behind programming solutions, evaluated alternative implementation approaches, and recommended optimal methods to ensure accurate, efficient, and consistent implementation aligned with the SAP and study specifications.
- Played a key role in FDA submission readiness by resolving complex Pinnacle 21 validation findings and supporting multiple Dry Runs, DMC reviews, and safety data deliveries while meeting aggressive project timelines.
- Recognized as a technical resource for troubleshooting programming challenges, identifying root causes of data and programming issues, and recommending practical, compliant solutions across cross-functional teams.
Principal Statistical Programmer (FSP) - Gilead Sciences
(2019-11 - 2022-02)
- Supported multiple global virology studies transitioning from double-blind to open-label phases.
- Developed reusable SAS macros and enhanced company utility libraries to improve programming efficiency, flexibility, and consistency across studies.
- Led validation activities by reviewing programming outputs, SAPs, table shells, and ADaM specifications; resolved discrepancies and ensured consistent implementation across study deliverables.
- Collaborated closely with statisticians to clarify endpoint derivations, support urgent analyses, and deliver high-quality programming outputs.
Senior Statistical Programmer (FSP) - BeiGene Inc.
(2018-04 - 2019-10)
- Supported multiple oncology clinical trials, including dry runs and key safety deliverables such as DMC, IDMC, DSUR, and other regulatory and clinical reporting activities.
- Developed and validated CDISC-compliant ADaM datasets supporting oncology efficacy and safety analyses, ensuring traceability from aCRF through SDTM, ADaM, and TLFs.
- Applied, enhanced, and maintained company-standard utility macro libraries for population summaries, categorical and continuous statistical reporting, ODS RTF generation, and automated log validation. Developed reusable study-specific utility macros for AE/CM partial date imputation, ISO 8601 (DTC) conversion, visit-to-analysis visit mapping, and other programming utilities to standardize programming processes, improve code reusability, and increase programming efficiency.
Senior Statistical Programmer (Contractor) - Amgen Inc.
(2012-04 - 2018-04)
Supported oncology clinical development programs for approximately six years, contributing to multiple studies from study start-up through regulatory submission.
- Developed and independently validated CDISC-compliant SDTM and ADaM datasets, along with Tables, Listings, and Figures (TLFs), ensuring compliance with study specifications, Statistical Analysis Plans (SAPs), CDISC standards, and company programming guidelines.
- Supported FDA regulatory submission activities by generating Define.xml using company metadata tools and utility macros; validated ADaM datasets and Define.xml using company validation tools and Pinnacle 21; investigated and resolved validation findings; reviewed SDRG and ADRG for consistency with submitted datasets; and ensured metadata accuracy, traceability, and compliance with CDISC SDTM/ADaM standards and FDA submission requirements.
- Developed publication-quality statistical graphics using SAS, including Kaplan–Meier survival curves (OS, PFS, and RFS), forest plots with hazard ratios or response rates and 95% confidence intervals, waterfall plots (Best Overall Response), spider plots (longitudinal tumor response), swimmer plots (duration of response and treatment exposure), bar charts (ORR, DCR, and BOR), and customized ODS Graphics to support Clinical Study Reports (CSRs), regulatory submissions, and clinical presentations.
SAS Programming Consultant (Contractor) - K&L Consulting Services, Inc. - Fort Washington, PA
(2008-11 - 2012-04)
Served as the CRO Study Lead Programmer for multiple clinical studies, acting as the primary programming contact between the CRO and sponsor.
- Participated in weekly sponsor meetings to provide programming status updates, discuss study timelines, review data quality and vendor data transfer issues, resolve SAP and analysis-related questions, track statistical programming deliverables, and coordinate programming activities with Biostatistics, Data Management, Clinical Operations, and sponsor teams.
- Developed and independently validated analysis datasets and statistical outputs for multiple clinical studies. Reviewed and contributed to Statistical Analysis Plans (SAPs), mock TLFs, programming specifications, and company programming standards.
- Led the validation and testing of the Analysis Dataset System (ADS) and Oncology Clinical Data Analysis and Reporting (OCDAR) management systems. Developed GUI test scripts, executed system validation using standard test cases, and independently verified ADaM datasets and standard oncology table outputs through pilot studies and quality control programming.
- Developed user manuals and training materials and delivered classroom and web-based training sessions for ADS and OCDAR systems. Provided hands-on guidance for generating ADaM datasets, tables, and listings using company-standard SAS macros and programming workflows.
SAS Programming Consultant (Contractor) - ClinForce / GlaxoSmithKline Inc. - King of Prussia, PA
(2007-05 - 2008-11)
Supported oncology clinical trial programming by developing and validating analysis datasets and statistical outputs for int
