Statistical Programmer Senior Manager

Looking for A “Statistical Programmer” Position

PROFESSIONAL HIGHLIGHT

Results-driven Principal Biostatistical Programmer with 19 years of SAS and 3 years of R programming experience in the pharmaceutical industry, with a strong focus on oncology research.

Proven expertise in managing statistical programming workflows across Phase I–IV clinical trials.

Regulatory submission support for FDA, EMA, and PMDA. Adept in CDISC standards (SDTM, ADaM) and FDA submission components such as ISS/ISE and BIMO listings.

Known for leading cross-functional programming teams, developing standardized macros, and automating TFL production to ensure data accuracy and reporting efficiency.

Programming: SAS (v9.4), R (ggplot2, tidyverse), SAS SQL.

Standards & Tools: CDISC SDTM/ADaM, Pinnacle 21, OpenCDISC Validator, define.xml

Systems: UNIX/Linux, Windows

Specialty: BIMO Listings, ISS/ISE, TLF Generation, Macros, Data Visualization

EXPERIENCE

Principal Statistical Programmer Dec. 2024 – Present

Independent Advisor – Statistical Programming

Managed CDISC-compliant SDTM and ADaM datasets; created TFLs for clinical reporting.

Refined and maintained global SAS macros for enhanced automation and data consistency.

Senior Manager, Statistical Programming Jan 2024 – Nov 2024

Senior Principal Biostatistical Programmer May 2023 – Dec 2023

Principal Biostatistical Programmer July 2019 – Apr. 2023

Taiho Oncology, Inc. (Astex Pharmaceuticals acquired by Taiho), Pleasanton, CA

Biostatistics and Data Management Department

Led programming for pivotal Phase II studies and contributed to FDA submissions for a Phase II study.

Developed BIMO PDF listings, created standardized SAS programs, and optimized reporting pipelines.

Created standardized SAS programs to generate tables, listings, and graphical clinical data reports, optimizing reporting efficiency.

Created/QCed CDISC ADaM dataset (such as ADSL, ADAE, ADCM, ADLB, ..) for multiple studies.

Reviewed SAPs, Table Shells, and Data Presentation Plans to align with project objectives.

Principal Statistical Programmer Dec 2018 – June 2019

Rigel Pharmaceuticals Inc., South San Francisco, CA

Reviewed CRFs and SAPs; created CDISC-compliant datasets (SDTM/ADaM).

Developed SAS programs for TLGs using Base SAS, SAS/GRAPH (GTL), and SAS/ODS.

Created and validated CDISC-compliant SDTM and ADaM datasets for regulatory submissions.

Automated clinical TFLs and graphical outputs using custom macros and GTL.

Senior Manager Feb. 2015 – Nov. 2018

Puma Biotechnology, South San Francisco, CA

Developed and optimized SAS macros for AE, demographics, survival analysis (KM), lab shifts, Forest Plots, Hy’s Law, and waterfall plots.

Led RTF summary table automation, improving efficiency in clinical reporting. worked on define.xml generation using Pinnacle 21.

Created %MedDRA_upv macro for MedDRA up-versioning and standardized existing macros for summary tables.

Generated patient-profile plots and bar charts for Study 6201 dashboard.

Supported FDA submissions with BIMO PDF Listings and ensured CDISC SDTM/ADaM compliance.

Statistical SAS Developer Aug. 2014 – Jan. 2015

Medivation, Inc., San Francisco, CA

Generated AE summary tables, RTF/PDF output reports, and waterfall plots.

Enhanced and Refined existing macro to handle partial dates for age calculations, and standardized dates and times in ISO 8601 format.

Senior Statistical Programmer Jan. 2014 – Aug. 2014

XOMA Corporation, Berkeley, CA

Performed QC and production of ADaM datasets (ADSL, ADEX, ADAE, ADCM) for EYEGUARD studies.

Used OpenCDISC Validator to generate compliance reports for SDTM datasets.

Developed %t_visit, %t_safety, and %t_demog macros to automate efficacy, safety, and demographic reporting.

Applied CDISC SDTM/ADaM standards, ensuring regulatory compliance and dataset consistency.

Senior Statistical Programmer Oct. 2012 – Jan. 2014

Pharmacyclics Inc., Sunnyvale, CA

Developed Tables, Listings, and Patient-Profile Graphs for Study PCYC-1112 (Phase II).

Created macros (%pp_listing, %GET_HEADER, %sas2rtf) to automate patient-profile listings, program headers, and RTF report generation.

Enhanced %compare_data macro to efficiently compare SAS datasets across directories.

Developed %firstpage macro to merge first pages of multiple RTF reports into a single file.

Senior SAS Lead Programmer July 2008-Oct. 2012

Amgen Inc., Thousand Oaks, CA

Developed macros for hepatotoxicity analysis, exposure graphs, and patient profile plots (%pp_line_plot).

Automated RTF Table/Listing QC by enhancing %readrtf_qc macro.

Generated and validated CDISC SDTM/ADaM datasets, summary tables, listings, and figures.

Created and validated AE Incidence and Lab Tables for multiple phase II and phase III projects.

PREVIOUS EXPERIENCE

Senior SAS Programmer, IKARIA / INO Therapeutics, Clinton, NJ

Statistical SAS Programmer, MannKind Corporation, Paramus, NJ, BioMetrics Department

Statistical SAS Programmer, 3M Pharmaceuticals, St. Paul, MN

EDUCATION

Certificate, Object-Oriented Programming and Analysis Seneca College of Applied Arts and Technology

Certificate, Advanced Statistics & Applied Mathematics Mathematics East China Normal University

Bachelor of Applied Mathematics Department of Mathematics and Physics Wuhan University of Technology

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