TWINKLE KALLOOR SEBASTIAN
Seattle,WA
Summary
Statistical Programmer with 5+ years of experience in SAS programming for Phase I–III clinical trials, specializing in SDTM and ADaM development, TLF generation, and SAP-driven analyses. Proven track record of delivering CDISC-compliant, submission-ready datasets and performing independent validation of efficacy and safety outputs. Strong expertise in oncology studies, regulatory standards, and cross-functional collaboration in GCP-compliant environments.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Clinical Data Programmer Trainee
Octovion
Seattle, WA
09.2025 - Current
- Developed SAS programs for analysis datasets and Tables, Listings, and Figures (TLFs) for oncology clinical trials.
- Supported SDTM and ADaM dataset preparation following CDISC standards.
- Perform data validation, data cleaning, and SAE reconciliation.
- Collaborated with cross-functional teams to ensure data integrity and compliance with regulatory standards.
- Developed and validated statistical programming code for clinical trial data analysis.
- Implemented automated reporting tools, improving data accessibility for stakeholders.
- Optimized database queries, reducing processing time and enhancing system performance.
Statistical Programmer
EMMES
Rockville, MD
01.2021 - 01.2024
- Programmed SDTM and ADaM datasets according to CDISC standards for Phase I–III clinical trials.
- Generated TLFs based on Statistical Analysis Plans (SAPs) using SAS.
- Performed independent validation of efficacy and safety outputs to ensure accuracy and traceability.
- Developed and maintained SAS macros to improve programming efficiency and standardization.
- Supported eCRF design, edit checks, and clinical database build.
- Produced Define-XML and supported regulatory submission deliverables.
- Ensured compliance with GCP, HIPAA, and 21 CFR Part 11 requirements.
- Collaborated with biostatisticians and data managers to meet study timelines and quality standards.
Program Manager
Little Franklin Academy
01.2016 - 01.2020
- Designed data tracking and reporting systems using quantitative methods to monitor performance and outcomes.
- Managed operations, program development, and stakeholder reporting.
- Implemented operational processes to streamline administrative tasks and improve efficiency.
- Developed curriculum frameworks that enhanced student engagement and learning outcomes.
Graduate Research Assistant – Biostatistics
University of Missouri
Columbia, MO
01.2012 - 01.2015
- Created SAS and SPSS datasets and conducted longitudinal and mixed-effects analyses.
- Generated statistical reports, tables, and summaries for publications.
Education
M.S. - Biostatistics
University of Missouri
B.E. - Computer Science and Engineering
N.S.S. College of Engineering
KeralaSkills
- SAS Programming: Base SAS
- SAS Macros
- CDISC & Regulatory: SDTM
- ADaM
- Define-XML
- TLFs
- SAP implementation
- Pinnacle 21
- CDISC validation
- HIPAA
- 21 CFR Part 11
- Other Programming / Tools: R
- SQL
- SPSS
Websites
Accomplishments
- Achieved [Result] through effectively helping with [Task].
- Collaborated with team of [Number] in the development of [Project name].
- Supervised team of [Number] staff members.
Certification
- SAS Certified Specialist – Base Programming Using SAS 9.4
- SAS Advanced Professional Certificate – Coursera
- Hands-On Clinical Reporting Using R – Coursera
- REDCap Project Design – University of Washington
- Foundations of Clinical Research – Seattle Children’s
- Google Project Management Certificate
Timeline
Clinical Data Programmer Trainee
Octovion
09.2025 - Current
Statistical Programmer
EMMES
01.2021 - 01.2024
Program Manager
Little Franklin Academy
01.2016 - 01.2020
Graduate Research Assistant – Biostatistics
University of Missouri
01.2012 - 01.2015
B.E. - Computer Science and Engineering
N.S.S. College of Engineering
M.S. - Biostatistics
University of Missouri