Tanushree Kundu
Bengaluru
Summary
Senior Statistical Programmer with extensive experience in clinical trial data analysis, statistical programming, and regulatory submissions. Proficient in SAS and skilled in developing and validating analysis datasets, tables, listings, and figures in compliance with CDISC standards (SDTM/ADaM). Experienced in supporting Phase III clinical studies, ensuring data quality, and meeting regulatory requirements for FDA and other health authorities. Known for strong problem-solving ability, attention to detail, and effective collaboration with biostatistics, data management, and clinical teams.
Overview
4
4
years of professional experience
5
5
years of post-secondary education
Work History
Senior Statistical Programmer
Eli lilly and Company
Bangalore
04.2025 - Current
- Worked on CRT annotation, SDTM, ADAM, TFL creation for Diabetes portfolio. Worked as a co-leader of a phase III study.
- Worked on regulatory submission, CRT package creation, P21 issues.
- Have been part of SME group for data visualization using spotfire for TLSRs.
- Worked on ARDS creation of the outputs.
- Worked on various milestones as DMC, TLSR, Database Lock, topline, non topline submissions.
- Being part of Backgroom of audit. Created audit inspection pre-requisite documents.
- Programmed and validated SAS code for data manipulation and reporting.
- Collaborated with cross-functional teams to ensure compliance with regulatory standards.
- Mentored junior programmers on statistical programming techniques and best practices.
- Conducted quality control checks on datasets to ensure accuracy and integrity.
- Assisted in the preparation of submission documents for regulatory agencies.
- Participated in project meetings to discuss timelines and deliverable expectations.
- Tested, debugged, validated and maintained existing SAS programs written by other programmers or analysts.
- Reviewed statistical analysis plans and generated specifications for the programming of analyses.
- Developed SAS programs to generate tables, listings and figures for clinical trial reports.
- Attended Phuse SDE.
Statistical Programmer
Eli lilly and Company
Bangalore
07.2022 - 03.2025
- Developed and validated statistical programs for clinical trial data analysis.
- Collaborated with cross-functional teams to ensure data integrity and accuracy.
- Utilized SAS software for data manipulation and reporting tasks efficiently.
- Worked as a buddy for new joiners.
Business Analyst
Genpact
Bangalore
09.2021 - 06.2022
- Worked as a credit risk model validator to understand and validate the model using SAS and make proper documentation of the findings.
Education
Master of Science - Statistics
University of Calcutta
Kolkata , 08.2019 - 08.2021
Bachelor of Science - Statistics
University of Calcutta
Kolk 07.2016 - 07.2019
Skills
- SAS programming
- data visualization
- regulatory compliance
- statistical analysis
- Statistical analysis expertise
- R programming basic knowledge
Accomplishments
- Innovation award: for making spotfire dashboard and modifying it to make it easy and interactive.
- Rise award: for productivity and delivery.
Timeline
Senior Statistical Programmer
Eli lilly and Company
04.2025 - Current
Statistical Programmer
Eli lilly and Company
07.2022 - 03.2025
Business Analyst
Genpact
09.2021 - 06.2022
Master of Science - Statistics
University of Calcutta
08.2019 - 08.2021
Bachelor of Science - Statistics
University of Calcutta
07.2016 - 07.2019