Sravya Vutukuru
Marlboro,USA
Summary
Senior SAS Programmer with extensive experience in statistical programming for clinical trials. Expertise in developing SDTM and ADaM datasets, leading Sigma tool implementation, and ensuring compliance with CDISC and FDA standards. Proven ability to deliver high-quality, validated datasets while collaborating effectively with cross-functional teams.
Overview
1
1
Certification
10
10
years of professional experience
Work History
Senior Statistical Programmer
Pfizer
, New Jersey
09.2024 - 05.2026
- Led setup, configuration, and implementation of Sigma standards tool, ensuring integration of clinical data workflows and CDISC compliance across multiple studies.
- Acted as central liaison between standards programming team and clinical study teams, facilitating integration of standardized deliverables across therapeutic areas.
- Support standardization of SDTM and ADaM datasets, ensuring consistency, reusability, and compliance with Pfizer's global data standards.
- Supported rollout and optimization of Sigma tool, providing maintenance, troubleshooting, and user support to enhance programming processes.
- Collaborating closely with study teams to identify and resolve technical and data-related issues, ensuring timely delivery of analysis-ready datasets and submission deliverables.
- Conducting quality checks and validation of standard macros, templates, and specifications used across clinical trials.
- Performed User Acceptance Testing (UAT) and system validation activities to ensure data quality and assess end-to-end workflows during tool updates and standard fixes.
- Successfully completed Sigma tool adoption and supported study teams with standards implementation, issue resolution, and seamless integration into ongoing projects. Designed and implemented a Smlink-driven framework to support standardized directory structures and reusable programming assets.
Senior Statistical Programmer
Ephicacy
, New Jersey
07.2022 - 12.2023
- Developed and validated SDTM and ADaM datasets across multiple therapeutic areas, ensuring compliance with CDISC standards and regulatory submission requirements.
- Performed data analysis validation and created programs based on detailed specifications to support clinical trial analysis and reporting.
- Contributed to Data Monitoring Committee (DMC) deliverables by developing standardized macros for generating consistent and accurate TLFs.
- Participated in the implementation and testing of Pfizer's Sigma project, including development of a GUI interface and creation of standardized programs (e.g., for PROC LOGISTIC).
- Executed parameter lookups and integrated datasets using CDARS, enhancing data accessibility for analysis.
- Extracted and annotated P21 validation reports, providing documented solutions to ensure FDA submission readiness.
- Troubleshot and updated standard macros, ensuring accurate outputs aligned with study requirements across clinical programs.
- Served as a validation and production programmer for SDTM snapshots, supporting ongoing data integrity and submission deliverables.
- Supported incident management efforts by identifying necessary updates to standard programs, ensuring continuous process improvement and compliance.
- Ensured compliance with ISO 9001/27001 principles, 21 CFR Part 11, FDA, and GCP guidelines while supporting CRO collaborations and clinical data throughout the drug development lifecycle.
- Demonstrated strong command of UNIX commands and scripting to manage files, run programs, and automate routine tasks in a multi-platform environment.
- Leveraged deep understanding of Pfizer-specific tools and processes to ensure consistent and compliant data delivery.
- Successfully contributed to the implementation of Pfizer's Sigma project, in the creation of standard program like PROC LOGISTIC.
- Developed and maintained standardized macros for DMC deliverables, improving consistency and reducing manual effort.
- Resolved critical Pinnacle 21 validation issues, ensuring compliance for regulatory submissions.
- Played a key role in incident management, updating standard programs and minimizing delays across study teams.
- Streamlined SDTM/ADaM production by automating processes and ensuring alignment with Pfizer's internal tools like CDARS.
- Recognized for cross-functional collaboration and supporting timely and compliant data delivery across multiple studies and therapeutic areas.
Senior Programmer Analyst
IQVIA
, New Jersey
06.2019 - 07.2022
- Developed and maintained SAS programs for efficient data transfer and accurate generation of listings, tables, and figures.
- Led the implementation of complex ISS ADaM derivations, enhancing consistency and regulatory compliance in integrated analysis datasets.
- Developed and validated SDTM and ADaM datasets (e.g., ADTTE, ADSL, ADAE) per CDISC standards.
- Developed complex ISS ADaM derivations (e.g., AVISIT, ANL01FL, BASETYPE, PARAMCD).
- Generated Data Management and reconciliation listings to identify and address discrepancies between CRF and vendor data.
- Collaborated with Clinical Data Management to effectively resolve data and reconciliation issues, ensuring data integrity.
- Created edit checks to support data cleaning and quality assurance.
- Imported and validated lab vendor data (e.g., QUEST, LABCORP); reviewed import agreements.
- Ensured compliance with corporate SOPs, timelines, and documentation standards.
- Improved project planning accuracy by providing input on biostatistical metrics and resource allocation.
- Supported cross-functional teams and enhanced knowledge in clinical trials and industry standards.
- Played a critical role in streamlining departmental processes by contributing to SOP and workflow enhancements.
- Served as a go-to expert for programming escalations, resolving complex issues efficiently across studies.
SAS Programmer Analyst
Accenture
, New Jersey
03.2016 - 05.2019
- Provided SAS programming support for New Drug Applications (NDA) and e-submissions, including define.pdf creation.
- Produced and validated SDTM and ADaM datasets, ensuring compliance with CDISC standards for regulatory submissions.
- Successfully supported multiple NDA submissions by delivering validated SDTM/ADaM datasets and high-quality TLFS for ISS and ISE.
- Generated and validated Tables, Listings, and Figures (TLFs) for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) analyses, contributing to comprehensive study reporting.
- Ensured regulatory compliance by contributing to e-submissions, including the creation of define.pdf and standardized documentation.
- Developed and validated code for statistical analyses, including survival analysis and Kaplan-Meier plots (PROC LIFETEST, PROC PHREG).
- Produced accurate Kaplan-Meier plots and statistical outputs using advanced SAS procedures.
- Applied SAS procedures and macros (e.g., PROC FREQ, PROC MEANS, PROC REPORT) for data cleaning and reporting.
- Improved data quality and efficiency by implementing robust SAS programs and macros for data cleaning, integration, and reporting.
- Supported vendor deliverables by verifying data quality and ensuring alignment with internal requirements, enhancing overall project integrity.
- Recognized for proactive cross-functional collaboration and timely delivery of project milestones.
- Played a key role in reviewing study documents and identifying data discrepancies early, reducing rework and review time.
Education
Bachelor of Science - Computer Engineering
JNTUH
Hyderabad, India01-2014
Skills
- SAS programming
- ADaM development
- SDTM compliance
- Technical Skills: SAS (Base, Macro, STAT, SQL, GRAPH, ODS), R (base), Pinnacle 21, Definexml, MS Office applications Platforms like Windows and UNIX
- Data visualization
- Industry Knowledge: Regulatory compliance expertise Clinical trial expertise Experience working in multiple therapeutic areas, adapting statistical programming to various study needs
- Soft Skills: Cross-functional collaboration
Certification
None so far
Additional Information (Optional)
Languages: English, Hindi, Telugu.
Timeline
Senior Statistical Programmer
Pfizer
09.2024 - 05.2026
Senior Statistical Programmer
Ephicacy
07.2022 - 12.2023
Senior Programmer Analyst
IQVIA
06.2019 - 07.2022
SAS Programmer Analyst
Accenture
03.2016 - 05.2019
Bachelor of Science - Computer Engineering
JNTUH