Statistical Programmer Clinical Data

Baode (Bob) Xie Ph. D

Email: ***.***@*****.***, Tel: 650-***-****, Hayward, CA 94544

Qualification Summary

• Seasoned statistical programmer with over 15 years of industry experience in supporting phase I through phase IV studies and global regulatory submissions in CRO and pharma setting.

• Advanced SAS programming skills in SDTM, ADaM programming and TFLs creation.

• In-depth knowledge of molecular pathology, oncology, biology, biomarker discovery and analysis.

• Therapeutic area experience includes oncology, hematology, rare disease, age-related neurodegeneration, infectious disease, gastroenterology, inflammatory disease and rheumatology.

• Proficient in supporting data visualization using different tools, including R/Shiny, Tableau and Spotfire.

• Excellent communication, leadership, and collaboration skills. Professional Experience

Calico Life Sciences

Contracting Statistical Programmer, Biostatistics Jan 2025–Present

• Develop and validate statistical program (SAS, R) for clinical trial data analysis and reporting.

• Create and maintain analysis datasets (SDTM, ADaM) following regulatory guideline (FDA, EMA, ICH).

• Collaborate with biostatisticians, data managers, and other department to ensure accurate analysis and reporting, provide statistical input for clinical study design, perform ad-hoc analyses and/or simulations for clinical study.

• Generate statistical tables, listings, and figures (TFLs) for clinical study reports and regulatory submissions. BridgeBio (Clindata Insight)

Contracting Principal Statistical Programmer, Biostatistics July 2024–Dec 2024

• Develops specifications for SDTM and ADaM datasets, acts as the strategic and technical leader for rare disease phase 3 studies.

• Develops, validates, and documents programs & SAS Macros, retrieves clinical data and metadata from EDC systems, develops and maintains SAS programs to create SDTM and ADaM datasets & TFLs, eSUB package and performs QC of SDTM, ADaM datasets and TFLs.

Fortrea (formerly Labcorp/Covance)

Senior Lead Statistical Programmer, Biostatistics May 2021–June 2024

• Performs the role of Lead Statistical Programmer, reviewing SAPs and TFL mock shells from a programming perspective for studies.

• Develops specifications for SDTMs and ADaM datasets, define.xml, eSUB package acts as the strategic and technical leader for oncology studies.

• Develops, validates, and documents programs & SAS Macros, retrieves clinical data and metadata from EDC systems, develops and maintains SAS programs to create SDTM and ADaM datasets & TFLs, and performs QC of SDTM, ADaM and TFLs.

• Collaborates with bioinformatics, biomarker scientist, PK scientist, statistician and data management team to produce high quality analysis datasets for safety, efficacy and PK/PD analysis reports through performing data reconciliations, and creating DM, AE, CM, MH, EX, EC, LB, EG, VS, PC, PP, TU, TR, RS SDTM datasets as well as ADSL, ADAE, ADEX, ADLB, ADEG, ADPC, ADPD, ADPP, ADRS, ADTR, ADTTE, ADEFF ADaM datasets.

• Extensive program experience on solid and blood tumor biomarkers such as HER2, BRAF, EGFR, JAK/ STAT, KRAS, ALK, MET, RAF/MEK/ERK, TNF/NF-kB, TMB (Tumor mutation burden), CD3, CD19, PD-1 et al. Portola/Alexion (Ascents Group)

Contracting Senior Statistical Programmer, Biostatistics Apr 2019–Apr 2021

• Acted as the strategic and technical leader for hematology & oncology studies; developed, validated, and documented programs, SAS Macros; retrieved clinical data and metadata from EDC systems and created SDTM & ADaM datasets, define.xml.

• Programmed TLFs needed for analysis and reporting, including NDA submission (Andexxa®, Ondexxya® approved by FDA, EMA, PDMA), summaries (ISS/ISE), CSRs, DSUR, PSUR, IB for FDA, EMA and PMDA etc.

• Rendered support in generating analysis datasets and creating specified structure of TFLs for publication through creation of macros program and macro variables using advanced SAS & SQL techniques.

• Supported data manager, medical affairs in ad-hoc tasks such as non-CRF data collection and review, transmission, acquisition and verification, and Tableau data visualization. Genentech/Roche (US Medical Affairs)

Contracting Senior Statistical Programmer, Biostatistics & Data Sciences Feb 2018–Mar 2019

• Developed, validated, and documented programs, SAS Macros; retrieved clinical data and metadata from EDC systems and created SAS datasets; programmed TLFs needed for analyses and reporting, including for CSRs, DSUR, PSUR, IB, etc.

• Defined file format specifications and data transfer specifications for all non-CRF data collection and transfers to internal data operating systems or specific biomarker data repositories.

• Transformation of the non-CRF data (especially biomarker data, PK data) to CDISC standards SDTM.

• Oversaw the quality of SDTM datasets provided by CRO, provided technical expertise on SDTM mapping strategy, independently delivered the mapping specifications and developed and executed mapping programs.

• Developed automated data transfer & analysis tools, programmed generating biosample reconciliation and tracker report.

• Used R to pull biomarker data from warehouses and perform analysis in R. Used R(Shiny) to develop a web platform which allows colleagues to access and analyze clinical data. The site should allow user’s significant analysis flexibility while keeping the raw data confidential.

• Used Tableau & Spotfire to quickly visualize and analyze medical review data. ABSBIO Hayward, CA

Clinical Programmer/Manager Jul 2014–Feb 2018

• Planned and managed all program activities. Solid knowledge and excellent experience in FDA regulations, data management and data analysis.

• Extensive understanding of R&D, clinical study data with hands-on experience in data manipulation, analysis and reporting.

• Designed, developed, evaluated and modified R & SAS programs for R&D and clinical data analyses, analyzed and validated datasets and outputs using SAS, R & SQL.

• Rendered support in generating analysis datasets and creating specified structure of TFLs through creation of macros and macro variables using advanced SAS, R & SQL techniques.

• Oversaw assay development and manufacturing of bioassay kits and services for biological samples. Bioassay Systems Hayward, CA

Data Scientist Aug 2008–Jul 2014

• Provided operational support by creating tables and graphs to produce inventory reports using excel and SQL, SAS, R program.

• Bioinformatics consult included: NCBI/BLAST, UCSC genome, Sequence alignment, Gene expression (NGS) analysis, Galaxy, R Bioconductor packages (Biobase, DESeq2, edger, limma, ggplot2, Shiny, tidyr, dplyr, devtools, tidyverse, admiral, tplyr, metacore/metatools et al), Python & HTML Web development. UCSF San Francisco, CA

Scientist, Advanced Genntic Systems Aug 2005–Aug 2008

• Developed cell-based reporter assays to monitor HIV Rev-RRE interactions as high-throughput screen method for identifying specific inhibitors of RNA-protein interactions.

• Identified small number analogs as anti-HIV compounds (NIH SBIR/STTR grant). Education

Ph.D. in Molecular Pathology, Kitasato University, Tokyo, Japan M.S. in Pharmacology & Toxicology, Jilin University, Changchun, China B.A. in Veterinary Medicine, Jilin University, Changchun, China Certifications

• SAS Certified Clinical Trials Programmer for SAS 9 Certificate No: CTP001437v9

• SAS Certified Advanced Programmer for SAS 9 Certificate No: AP021467v9 Technical Skills

• Tools: SAS/Base, SAS/Stat, SAS/Graph, JMP, SQL, Python, R, P21, Rave Medidata, Veeva, Tableau, Spotfire

• Statistical software: STATA, SPSS, Phoenix PK/PD

• Operating Systems: UNIX, WINDOWS, LINUX, LIMS

• Web Technologies: HTML, JavaScript, R Shiny App

• Scientific Skills: Molecular Biology, Cell Biology, Bioassay, Bioinformatics, Molecular Pathology & Oncology

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