MITYL BISWAS
Greater Philadelphia Area
Summary
Accomplished Clinical Development Biostatistician with a PhD in Statistics and extensive experience leading Phase I and III oncology and immunology studies. Delivers statistical leadership through innovative trial design, adaptive methodologies, and regulatory strategy. Collaborates with cross-functional teams to translate complex quantitative findings into actionable strategies and informed decisions, ensuring high-quality outputs aligned with ICH-GCP standards.
Overview
12
12
years of professional experience
Work History
Principal Statistician
TEVA PHARMACEUTICALS
West Chester
04.2022 - 05.2026
- Served as statistical lead for three Phase I clinical trials, independently providing end-to-end statistical leadership across protocol development, analysis strategy, SAP authoring, randomization plan authoring, study startup, interim analyses, DMC charter review, DMC and DRC membership, TFL review, endpoint strategy, database lock preparation, DSUR and CSR contributions in alignment with regulatory expectations for oncology and immunology studies.
- Led biometrics for part of a Phase III asthma study, leading design and strategy, applying Bayesian and simulation-based methodologies for sample size determination, operating characteristic evaluation, and adaptive sample size re-estimation to support efficient, quantitative, data-driven clinical development decisions.
- Translated statistical outputs into actionable clinical development recommendations and development implications for clinical decision-makers, supporting data-driven go/no-go, indication selection, and model-informed decisions through integration of statistical analyses with clinical and pharmacological insights.
- Developed and defended statistical methodology choices during internal governance (PRC review) and regulatory-facing review processes, ensuring alignment with clinical objectives and submission requirements.
- Founded and led a departmental statistical knowledge-sharing forum, organizing quarterly sessions on emerging methodologies and enabling interdisciplinary learning across statistical and non-statistical functions.
- Supported regulatory submissions, including IND-supporting deliverables and briefing books, through high-quality statistical documentation, analysis outputs, CSR contributions, and preparation of regulatory responses with statistically sound interpretation and justification of methodologies in collaboration with senior statisticians, aligned with ICH-GCP and regulatory expectations for clinical trial submissions.
- Led oversight and quality review of CRO deliverables, ensuring compliance with protocols and statistical analysis plans, and alignment with study objectives.
- Contributed to statistical process development and standardization and operational excellence initiatives.
- Ensured compliance of SDTM and ADaM datasets with regulatory standards.
Research Assistant For Department Of Teacher Education And Learning Sciences
NC STATE UNIVERSITY
Raleigh
06.2018 - 05.2021
- Managed large-scale datasets for NCDPI-funded research initiative, performing data cleaning, exploratory and confirmatory factor analyses, and longitudinal and comparative analyses of school scores, disciplinary trends in disabled and non-disabled populations, and teacher satisfaction across 2,500+ schools, informing statewide assessment and policy decisions.
- Conducted statistical analysis for peer-reviewed scientific publication, contributing to validated research findings.
PhD Data Science Intern
UNITED HEALTH GROUP
Minnetonka
06.2019 - 08.2019
- Analyzed large datasets to identify trends and support decision-making processes.
- Collaborated with cross-functional teams to define project requirements and deliver actionable insights.
- Integrated healthcare claims and biometric datasets to evaluate predictive associations that informed business initiatives.
Teaching Assistant For Department Of Statistics
Nc State University
08.2014 - 05.2018
- Designed and maintained academic websites, provided 1:1 mentoring, proctored exams and graded coursework.
Education
PhD - Statistics
North Carolina State University
U.S.A.M.Stat and B.Stat (Hons.) - Biostatistics, Data Analysis
Indian Statistical Institute
Kolkata, IndiaSkills
- Clinical Development Strategy
- Statistical Leadership
- Scientific collaboration
- Trial design
- Bayesian methods
- Simulation Strategy
- Operating Characteristics
- Quantitative Decision-Making
- Risk assessment
- Protocol Development
- Statistical Analysis plan
- Sample size determination
- Statistical Modeling
- PK/PD and Safety Analytics
- Statistical deliverables
- Regulatory Compliance
- CDISC
- Process standardization
- Clinical Study Reports
- Patient-Reported Outcomes
- Dose Response Studies
- Interim Analysis
- AI Applications
- R
- SAS
- Python
- EAST
- FACTS
- Spotfire
- Microsoft Office
Websites
Accomplishments
- TEVA STARS PLATINUM STAR FOR FOCUS AND ACCOUNTABILITY, USA
DBL and CSR delivered under accelerated timelines, 2025 - TEVA STARS BRONZE STAR FOR FOCUS AND ACCOUNTABILITY, USA
Stepped in for a colleague to submit deliverable under a tight timeline, 2022
Timeline
Principal Statistician
TEVA PHARMACEUTICALS
04.2022 - 05.2026
PhD Data Science Intern
UNITED HEALTH GROUP
06.2019 - 08.2019
Research Assistant For Department Of Teacher Education And Learning Sciences
NC STATE UNIVERSITY
06.2018 - 05.2021
Teaching Assistant For Department Of Statistics
Nc State University
08.2014 - 05.2018
M.Stat and B.Stat (Hons.) - Biostatistics, Data Analysis
Indian Statistical Institute
PhD - Statistics
North Carolina State University