Vivek Ravipati
Boston
Summary
Accomplished Principal Statistical Programmer at Takeda Pharmaceuticals, leveraging expertise in SAS and R to enhance data validation and streamline submission processes. Proven ability to lead teams and mentor junior programmers, ensuring compliance with FDA and CDISC standards while delivering high-quality datasets and reports.
Overview
18
18
years of professional experience
Work History
Principal Statistical Programmer
TakedaPharmaceuticals
Boston
12.2021 - Current
- Established standard SAS macro library to enhance programming efficiency.
- Oversaw CRO activities, validating data and ensuring compliance with submission requirements.
- Developed local and global macros for workflow automation, improving productivity.
- Executed data analysis using SAS, R, and Python for validation and report generation.
- Provided technical support for SAS programming and maintenance within biometrics team.
- Created CTCAE v5 macro to support oncology biometrics initiatives.
- Reviewed protocols and SAPs, collaborating with statisticians to resolve discrepancies.
- Validated oncology datasets ensuring adherence to FDA guidelines and CDISC standards.
Sr. Lead SAS Programmer
ABBVIE Pharmaceuticals
Waukegan
06.2018 - 11.2021
- Led development and unit testing of SDTM and ADaM detailed designs, ensuring seamless deployment.
- Managed CRO oversight and vendor communications, serving as SME for deliverables.
- Reviewed SAP and SPP, offering feedback on oncology (solid and hematology) studies.
- Developed various SAS macros, including %pp_listing, %GET_HEADER, %sas2rtf, and others.
- Created SAS macro %KM_curve for generating Kaplan-Meier Curves.
- Implemented R and SAS analytics to support data analysis reports.
- Converted DOC files to RTF using SAS macro %doc2rtf for streamlined document management.
- Supported clinical trial design mapping to CDISC SDTM through solid clinical data knowledge.
Sr. SAS Programmer
Bioverativ
Waltham
01.2017 - 06.2018
- Delivered SDTM datasets, ADAM efficacy, and safety analysis datasets for multiple clinical trials using SAS software.
- Created eCRT packages including Define.XML, SDTM Reviewers Guide, and Annotated CRF for NDA submissions.
- Prepared final eCTD documents, ensuring readiness through Pinnacle 21 runs.
- Developed ISS/ISE datasets and TLFs to support regulatory submissions.
- Applied knowledge of drug submission requirements and relevant ICH, FDA/EMEA guidelines.
- Integrated data across multiple studies at a drug program level to maintain standards.
- Communicated proactively regarding timelines, adjusting plans to mitigate risks.
- Managed moderate to large volumes of complex tasks with minimal guidance.
Sr. SAS Programmer Tech Lead
ABBVIE Pharmaceuticals
Waukegan
06.2016 - 12.2016
- Directed development and unit testing for SDTM and ADaM deployment, ensuring high-quality execution.
- Created SAS programs using SAS Macro and PROC SQL, leveraging CDISC expertise.
- Generated datasets with SDTM principles like RELREC, SUPPQUAL, and CO domain.
- Executed macros such as coderive and BLFL to boost SDTM processing efficiency.
- Applied SDLC methodologies across coding, testing, and deployment phases.
- Reviewed eCRFs for compliance and accuracy in data collection.
- Collaborated with principal consultant to validate eSubmission packages including eCRT and define.xml.
- Validated SDTM and ADaM datasets alongside summary tables and graphs independently.
MacroDeveloper
SAS, Puma Biotechnology
Los Angeles
09.2014 - 05.2016
- Developed SAS validation programs for SDTM and ADaM datasets.
- Gathered study team requirements, translating them into technical specifications for SAS programming.
- Generated SDTM datasets for oncology studies from raw data, adhering to CRF and CDISC SDTM guidelines.
- Created and validated ADaM datasets based on SDTM inputs, implementation guides, and company standards.
- Produced ADaM datasets and tables for ISE and ISS submissions to the FDA.
- Executed programming for SAS data validation checks to identify discrepancies.
- Integrated external data sources into primary clinical databases using SAS checks.
- Mentored junior SAS programmers while providing ad hoc statistical programming support.
Senior Statistical Programmer/Analyst
Bristol Myers Squibb Pharmaceuticals
Princeton
01.2012 - 09.2014
- Developed SAS macros for toxicity assessment, exposure graphs, and patient profile visualizations.
- Rewrote SAS macros for quality control and Excel data import into SAS datasets.
- Created and validated SDTM and ADaM datasets aligning with annotations and industry standards.
- Reviewed protocols, eCRFs, database designs, and provided feedback on DPP, SAP, and TLF shells.
- Generated Tables, Listings, and Graphs for regulatory submissions per protocol and SAP requirements.
- Utilized PROC MEANS, PROC FREQ, and other procedures for statistical analysis of clinical trial data.
- Coordinated statistical programming team to ensure timely completion of clinical studies.
- Uploaded data to internal website using JavaScript and HTML for company-wide presentations.
Clinical SAS Programmer
Certus International, Inc
St Louis
10.2009 - 11.2011
- Converted .XPT files to SAS Data Sets using PROC COPY for various datasets including DEM, ECG, and AELOG.
- Imported PKDATA and PKARDATA from .xls to SAS Data Sets through SAS Application environment.
- Developed NONMEM datasets for POPPK and ER with essential derived variables.
- Analyzed data and generated statistical reports with graphs for POPPK analysis and ER parameters.
- Maintained SAS data and statistical analysis programs to support drug development projects.
- Executed data transmission and integrity checks on SAS datasets.
- Wrote code in SAS/BASE and SAS/MACROS to extract data from ORACLE and MS ACCESS databases.
- Produced customized reports using PROC REPORT, PROC TABULATE, and SAS/ODS.
Clinical SAS Programmer
Globe Immune, Inc
Louisville
12.2007 - 09.2009
- Conducted clinical trial studies, extracting and migrating data from flat files, SQL tables, and SAS datasets.
- Created Case Report Tabulations (CRT) datasets adhering to CDISC standards for FDA submissions.
- Utilized Dynamic Data Exchange (DDE) to import Excel data into SAS for analysis.
- Extracted and validated SAS datasets from Oracle, employing SQL Pass-Through Facility.
- Analyzed Phase I, II, and III clinical trials and performed statistical analyses using SAS.
- Produced accurate tables and listings for Integrated Summaries of Efficacy and Safety.
- Collaborated with statisticians on SAP-related issues and presented potential changes effectively.
- Developed SAS macros for routine reporting and maintained compliance with regulatory standards.
Education
Master’s - health informatics
Saint Louis University
Skills
- SAS and R programming
- Statistical analysis tools
- Data visualization techniques
- Database management systems
- Microsoft Office suite
- Clinical trial management
- Regulatory compliance knowledge
- Data governance practices
Degree
MS. MHI
Timeline
Principal Statistical Programmer
TakedaPharmaceuticals
12.2021 - Current
Sr. Lead SAS Programmer
ABBVIE Pharmaceuticals
06.2018 - 11.2021
Sr. SAS Programmer
Bioverativ
01.2017 - 06.2018
Sr. SAS Programmer Tech Lead
ABBVIE Pharmaceuticals
06.2016 - 12.2016
MacroDeveloper
SAS, Puma Biotechnology
09.2014 - 05.2016
Senior Statistical Programmer/Analyst
Bristol Myers Squibb Pharmaceuticals
01.2012 - 09.2014
Clinical SAS Programmer
Certus International, Inc
10.2009 - 11.2011
Clinical SAS Programmer
Globe Immune, Inc
12.2007 - 09.2009
Master’s - health informatics
Saint Louis University