Madhu Bollempalli
Denton,TX
Summary
Detail-oriented Clinical SAS Programmer with 6+ years of experience in the pharmaceutical industry, supporting Phase I-IV clinical trials. Specializes in developing, validating, and submitting SDTM and ADaM datasets aligned with CDISC standards. Demonstrates expertise in generating regulatory-compliant safety and efficacy outputs (TLFs), collaborating with biostatisticians, data managers, and clinicians to deliver accurate and timely results for FDA/EMA submissions.
Overview
6
6
years of professional experience
Work History
Clinical SAS Programmer
Maxpertise Technology Labs
08.2017 - 09.2023
- Develop standard SAS programs and/ or study specific Macros for generating listings.
- Creation of standard SDTM and ADaM and/ or sponsor defined hybrid datasets
- Developed DM, AE, DS tables and change from baseline Shift Tables.
- Program protocol specific reports which aid in data cleaning, transformation and validation.
- Perform and document the development and validation of reports strictly adhering to process compliance.
- Expertise in handling and understanding report requirements directly from the clinicians.
- Experience on JReview and Entimice tools.
- Ability to understand the report objectives and creation of user report specification.
- Development of SAS based reports and datasets in Entimice and JReview tool.
- Worked on reports of various therapeutic areas ranging from simple CTCAE grading to complex cancer reports involving Lugano classification and RECIST evaluation criteria, cardiovascular GDMT reports, and vaccine visit windowing reports and protocol specific listings and tables.
- Provide insights to the end user, regarding the report layout and making the report convenient for reviewing.
- Involved in developing various reports like Missing Pages, Data Review Listings, Patient profiles, Global Physician reports and converting Rave Raw SAS on Demand datasets to sponsor defined pre-SDTM standard datasets.
- Created protocol specific macros based on report requirement example to derive CTCAE grades for laboratory tests according to CTCAE Specifications, importing data from previous report files to current file to aid in data review.
Education
Master of Science - Business and Data Analysis
Southern Arkansas University
Magnolia, AR05.2025
MBA - Business and Data Analysis
University of North Texas
Denton, TX05-2024
Bachelor of Commerce - Business Statistics
Karnataka University
DHARWAD08.2017
Skills
- CDISC Standards: SDTM
- CDISC Standards: ADaM
- Safety & Efficacy Reporting (TLFs)
- JReview & Entimice Reporting Tools
- Cross-Functional Collaboration
- Report Validation & Quality Assurance
- Study Protocol Review & Report Specifications
- SAS v94 (Base)
- SAS v94 (Macro)
- SAS v94 (Advanced)
- JReview v132
- Entimice
- SQL Developer
- Microsoft Excel
- Tableau
- Microsoft PowerPoint
Project Management Experience
- Experience in handling and hosting Client Meetings as per report requirement on daily basis.
- Worked with multiple stakeholders and made sure to meet the deliverable timelines.
- I was the OE Secondary SPOC (Operational Excellence) responsible for calculating team’s Quality, 3*3.
- I had provided Knowledge Sharing Sessions to the team on the topics:
- o Recent advances in gene therapy and molecular biotechnology.
o Understanding of biological terminologies (oncology, Immunology, molecular biology etc.,) to resources from non-biological
background
- I was the primary POC for process Level checks responsible for identifying process deviations of the team
Accomplishments
- Star of Business Excellence Award - Q1 & Q2 2022
- Lynchpin Award - 05/01/21, for excellence in multi-study report delivery
- Client Contribution Award - 03/01/21, for exceptional quality in critical reporting
- Delivered multiple FDA/EMA-compliant submissions on time
- Conducted knowledge sessions on gene therapy and biological data interpretation
Timeline
Clinical SAS Programmer
Maxpertise Technology Labs
08.2017 - 09.2023
Master of Science - Business and Data Analysis
Southern Arkansas University
MBA - Business and Data Analysis
University of North Texas
Bachelor of Commerce - Business Statistics
Karnataka University
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