Si Chen
Sunnyvale,CA
Summary
Senior Manager of Statistical Programming with 13+ years of experience leading statistical programming activities for global Phase I–III oncology and virology clinical trials supporting regulatory submissions to the FDA, PMDA, EMA, and Health Canada.
Recognized for combining strategic leadership with deep technical expertise, remaining actively involved in hands-on programming, SDTM/ADaM specification development, submission package preparation, and complex technical problem solving while leading cross-functional teams and mentoring statistical programmers.
Extensive experience leading pivotal Phase III studies, integrated analyses (ISS/ISE/ISI), regulatory submission deliverables, and CDISC implementation. Proven ability to drive high-quality submissions under aggressive timelines through close collaboration with Biostatistician, Clinical Development, Data Management, Medical Writing, Regulatory Affairs, and external vendors.
Overview
14
14
years of professional experience
Work History
Senior Manager, Statistical Programming
Gilead Sciences
Foster City, California
03.2025 - Current
Provide strategic and technical leadership for late-stage oncology clinical development programs supporting global regulatory submissions.
Key Responsibilities & Achievements
- Led statistical programming activities for a global Phase III pivotal oncology study from the first patient enrollment through regulatory submission.
- Successfully led statistical programming activities supporting the FDA approval of a pivotal oncology program.
- Manage and mentor a team of approximately 12 statistical programmers, providing technical leadership, workload planning, and career development.
- Provided strategic leadership and hands-on technical contributions, including SAS programming, ADaM specification development, SDTM specification review, and programming for CSR, ISS, ISI, regulatory RTQs, and ad hoc deliverables to support timely project milestones.
- Owned statistical programming submission package by leading preparation and quality review of Analysis Data Reviewer’s Guide (ADRG), Bioresearch Monitoring Data Review Guide (BDRG), define.xml, and submission metadata, ensuring regulatory compliance and inspection readiness.
- Oversee development, validation, and quality review of SDTM datasets, ADaM datasets, TFLs, define.xml, and submission deliverables.
- Review vendor-generated SDTM define.xml, Study Data Reviewer’s Guide (SDRG), and SDTM submission deliverables to ensure consistency with CDISC standards, and regulatory expectations.
- Drove submission readiness by leading programming strategy, conducting risk assessments, resolving issues, and ensuring quality review of all deliverables.
- Partner closely with Biostatistician, Clinical Development, Data Management, Medical Writing, Regulatory Affairs, and CRO partners to resolve complex technical and submission issues.
- Contributed actively to the enterprise ADaM Standard Working Group and Oncology ADaM Working Group, establishing programming standards and best practices.
Manager, Statistical Programming
Gilead Sciences
Foster City, California
09.2022 - 02.2025
- Served as Programming Lead for multiple oncology clinical studies throughout the development lifecycle.
- Led production and review of SDTM datasets, ADaM datasets, TFLs, define.xml, and ADRG.
- Developed SAS programs supporting efficacy, safety, and integrated analyses.
- Generated and reviewed SDTM mapping specifications and ADaM specifications.
- Led programming activities supporting ISS deliverables for regulatory submissions.
- Reviewed Statistical Analysis Plans, CRFs, TFL shells, programming specifications, and vendor deliverables.
- Collaborated with global CRO partners to ensure high-quality deliverables and on-time submissions.
- Conducted submission readiness reviews using Pinnacle 21 Enterprise.
- Developed reusable SAS utilities and programming standards to improve efficiency and consistency.
Senior Statistical Programmer
Gilead Sciences
Foster City, California
02.2019 - 09.2022
- Supported HIV and Oncology clinical development programs through statistical programming and regulatory submissions.
- Supported successful submission of a Phase III HIV program for Bictegravir.
- Developed and validated CDISC-compliant SDTM datasets, ADaM datasets, and TFLs.
- Led preparation of define.xml and Analysis Data Reviewer’s Guide (ADRG).
- Generated and reviewed SDTM mapping specifications and ADaM specifications.
- Developed oncology efficacy derivations according to RECIST and Cheson response criteria.
- Reviewed programming deliverables from internal teams and CRO partners.
- Performed submission validation using Pinnacle 21 Enterprise.
Senior Statistical Programmer
Bristol Myers Squibb
Tampa, Florida
01.2018 - 01.2019
- Supported Immuno-Oncology programs including Melanoma, Bladder Cancer, and Renal Cell Carcinoma.
- Developed and validated SDTM, ADaM datasets, and TFLs supporting FDA, EMA, and Health Canada submissions.
- Reviewed oncology dataset specifications based on RECIST 1.1.
- Developed reusable SAS macros and automated validation programs.
- Collaborated with CRO partners and global study teams.
Statistician
Children’s Oncology Group, University of Florida
Gainesville, Florida
03.2012 - 11.2017
- Performed statistical analyses for multiple Phase III pediatric oncology clinical trials.
- Conducted survival analysis, competing risks analysis, logistic regression, and linear regression using SAS and R.
- Produced biannual study progress reports and confidential data safety monitoring committee reports.
- Collaborated with Study committee in conduction statistical analyses for publications, conference abstracts, and ad hoc analyses.
- Developed reusable analytical macros and reporting tools.
- Collaborated with principal investigators on peer-reviewed publications.
Education
Master of Science - Biostatistics
University of Florida
Gainesville, FL12-2011
Bachelor of Science - Mathematics, Statistics
University of Florida
Gainesville, FL06-2009
Skills
- Statistical Programming Leadership
- Global Regulatory Submissions
- FDA, PMDA, EMA & Health Canada
- Phase I–III Clinical Development
- Oncology & Virology
- ADaM/SDTM Mapping Specifications
- BIMO Part III Mapping Specifications
- Definexml
- Analysis Data Reviewer’s Guide (ADRG)
- Study Data Reviewer’s Guide (SDRG)
- Bioresearch Monitoring Data Review Guide (BDRG)
- ISS / ISE / ISI
- Pinnacle 21 Enterprise
- SAS Programming & Macro Development
- RECIST 11
- Team Leadership & Mentoring
- Cross-functional Collaboration
- Vendor Oversight
Accomplishments
- UF College of Public Health and Health Professions Outstanding Alumni 2016
Publications
1. Eric C. Larsen, Meenakshi Devidas, Si Chen, Wanda L. Salzer, Elizabeth A. Raetz, Mignon L. Loh, Leonard A. Mattano Jr, Catherine Cole, Alisa Eicher, Maureen Haugan, Mark Sorenson, Nyla A. Heerema, Andrew A. Carroll, Julie M. Gastier-Foster, Michael J. Borowitz, Brent L. Wood, Cheryl L. Willman, Naomi J. Winick, Stephen P. Hunger, and William L. Carroll (2016). Dexamethasone and High-Dose Methotrexate Improve Outcome for Children and Young Adults with High-Risk B-Acute Lymphoblastic Leukemia: A Report from Children’s Oncology Group Study AALL0232. Journal of Clinical Oncology. DOI: 10.1200/JCO.2015.62.4544.
2. Sumit Gupta, Meenakshi Devidas, Si Chen, Cindy Wang, Mignon L. Loh, Elizabeth Raetz, Patrick Brown, Andrew J. Carroll, Nyla A. Heerema, Julie M. Gastier-Foster, Kimberly P. Dunsmore, Eric Larsen, Kelly Maloney, Leonard A. Mattano Jr., Stuart Winter, Naomi Winick, William L. Carroll, Stephen Hunger, Michael J. Borowitz and Brent L. Wood (2016). Minimal Residual Disease Assessment of Remission after Induction Therapy Is Superior to Morphologic Assessment for Risk Stratification in Childhood Acute Lymphoblastic Leukemia: A Report from the Children's Oncology Group (COG). American Society of Hematology. Blood 2016 128:758
3. Stuart S. Winter, Meenakshi Devidas, Si Chen, Barbara Asselin, William L. Carroll, Brent L Wood, Natia Esiashvili, Briegel J Nikki, Robert J. Hayashi, Mignon L. Loh,Andrew J. Carroll, Nyla A. Heerema, Elizabeth Raetz, Naomi J. Winick, Stephen P. Hunger, Kimberly P. Dunsmore (2015). Capizzi-Style Methotrexate with Pegasparagase (C-MTX) Is Superior to High-Dose Methotrexate (HDMTX) in T-Lineage Acute Lymphoblastic Leukemia (T-ALL): Results from Children's Oncology Group (COG) AALL0434. American Society of Hematology. Blood 2015 126:794.
4. Wanda Salzer, Michael J. Burke, Eric C. Larsen, Si Chen, Lia Gore, Joanne M. Hilden, Mignon L. Loh, Elizabeth Raetz, Naomi J. Winick, William L. Carroll, MeenakshiDevidas, Stephen P Hunger (2015). Incidence of Allergic Reactions to Pegaspargase (PEG) Administered Intramuscularly Versus Intravenously (IM vs. IV) in Children and Young Adults with High Risk B-Lymphoblastic Leukemia (HR B-ALL): Results of Children's Oncology Group (COG) Studies AALL0232/AALL1131. American Society of Hematology. Blood 2015 126:1303.
5. Brent L. Wood, Stuart S. Winter, Kimberly P. Dunsmore, Meenakshi Devidas, Si Chen, Barbara Asselin, Natia Esiashvili, Mignon L. Loh, Naomi J. Winick, William L.Carroll, Elizabeth A. Raetz, Stephen P. Hunger (2014). T-Lymphoblastic Leukemia (T-ALL) Shows Excellent Outcome, Lack of Significance of the Early Thymic Precursor (ETP) Immunophenotype, and Validation of the Prognostic Value of End-Induction Minimal Residual Disease (MRD) in Children’s Oncology Group (COG) Study AALL0434. American Society of Hematology. Blood 2014 124:1.
6. Leonard A. Mattano, Meenakshi Devidas, Si Chen, Natia Esiashvili, Barbara Asselin, Naomi J. Winick, Mignon Loh, Elizabeth A Raetz, Stephen Hunger, William L.Carroll, Stuart S. Winter, Kimberly P. Dunsmore (2014). Effect of High-Dose Methotrexate (HD-MTX) Vs Capizzi Methotrexate/Pegaspargase (C-MTX/ASNase) on Osteonecrosis (ON) Incidence in Children and Young Adults with T-Acute Lymphoblastic Leukemia (T-ALL): Results of Children’s Oncology Group (COG) Study AALL0434. American Society of Hematology. Blood 2014 124:3649.
7. Naomi Winick, Meenakshi Devidas, Si Chen, Kelly Maloney, Eric Larsen, Leonard Mattano, Michael J. Borowitz, Andrew Carroll, Julie M. Gastier-Foster, Nyla A. Heerema, Cheryl Willman, Brent Wood, Mignon L. Loh, Elizabeth Raetz, Stephen P. Hunger, William L. Carroll (2016). The Impact of initial cerebrospinal fluid findings on outcome among patients with NCI standard and high-risk B-lymphoblastic leukemia: A report from the Children’s Oncology Group. Submitted to Journal of Clinical Oncology.
Timeline
Senior Manager, Statistical Programming
Gilead Sciences
03.2025 - Current
Manager, Statistical Programming
Gilead Sciences
09.2022 - 02.2025
Senior Statistical Programmer
Gilead Sciences
02.2019 - 09.2022
Senior Statistical Programmer
Bristol Myers Squibb
01.2018 - 01.2019
Statistician
Children’s Oncology Group, University of Florida
03.2012 - 11.2017
Master of Science - Biostatistics
University of Florida
Bachelor of Science - Mathematics, Statistics
University of Florida