Rohit Chaturvedi
Mumbai
Summary
Sr. Biostatistical Programmer with 9+ years of experience providing technical leadership in CDISC, SDTM strategy, development, and quality oversight for global clinical studies. Proven expert in transforming raw clinical data into submission-ready SDTM datasets, aligned with SDTM IG, sponsor standards, mapping specifications, and TDDs. Extensive hands-on experience with Pinnacle 21 validation, define.xml creation and review, CRF annotation, SDTM data reconciliation, and regulatory submission support, recognized for strong cross-functional collaboration, and high client satisfaction.
Overview
9
9
years of professional experience
3
3
Certifications
Work History
Sr. Biostatistical Programmer
Premier Research
04.2025 - Current
- Lead SDTM strategy, design, and implementation across multiple clinical studies.
- Serve as the primary SDTM subject-matter expert for CDISC standards and sponsor-specific requirements.
- Review and approve SDTM mapping specifications, TDDs, and SDTM datasets.
- Ensure compliance with CDISC SDTM IG, FDA, and PMDA requirements.
- Oversee end-to-end SDTM dataset development from raw clinical data.
- Conduct high-level QC and review of SDTM datasets, define.xml, and CRF annotations.
- Ensure all deliverables pass Pinnacle 21, EDV and internal validation checks.
- Support regulatory submissions by delivering submission-ready SDTM datasets.
Assistant Manager-Clinical Data Services
Accenture Solutions Pvt Ltd
02.2021 - 04.2025
- Lead SDTM teams, drive automation, and ensure submission-ready CDISC SDTM deliverables.
- Hands-on expertise in SAS, SDTM mapping, Pinnacle 21, define.xml, and regulatory submissions.
- Strong client engagement, mentoring, and cross-functional collaboration.
- Support studies across multiple therapeutic areas including Gastroenterology, Neurology, Oncology, and Diabetes for Phase I, II, and III clinical trials.
- Conduct and facilitate knowledge-sharing sessions, technical training, and learning initiatives for team development.
- Perform RCA/CAPA, PLC activities, audits, and study-level reviews to maintain high standards and inspection-ready deliverables.
Senior SAS Programmer
IQVIA RDS (India) Private Limited
09.2020 - 01.2021
- Developed and validated SDTM datasets using SAS, adhering to CDISC implementation guidelines and client-specific documentation, followed by Pinnacle 21 review and QC checks.
- Reviewed and verified error logs from SAS programs and data systems, communicating and resolving issues effectively to ensure accurate data transmission.
- Maintained strong collaboration and communication with the statistics team to support study deliverables.
- Coordinated with internal and external stakeholders to negotiate timelines, responsibilities, and deliverables, ensuring project milestones were met.
Senior SAS Programmer
Tata Consultancy Services
01.2017 - 09.2020
- Performs the role as developer as well as Validator to create SDTM domains, listing Programs for Data Cleaning, Validation, and Analysis & Report generation.
- Serve as both SDTM Developer and Validator, creating SDTM domains and listing programs for data cleaning, validation, analysis, and report generation.
- Provide programming support to SDTM, Statistics, and Data Management teams, including domain validation, QC checks, data reconciliation, and standard data checks.
- Merge external vendor data with EDC data, ensuring consistency and generating SAE reconciliation, lab reconciliation, and vendor reconciliation listings.
- Transform raw data into SAS datasets, delimited files, and Excel formats for data review and analysis.
- Develop complex listings including CPT (Clean Patient Tracker), MRL (Medical Review Listings), DMRL (Data Management Review Listings), and Manual Listings.
- Strong command of SAS procedures such as PROC MEANS, PROC TRANSPOSE, PROC SORT, PROC PRINT, and advanced SAS programming techniques.
- Hands-on experience with SAS Base, SAS/SQL, SAS/ODS, SAS/ACCESS, and SAS Clinical.
- Spotfire Analyst
- Developed CSTV & SRT dashboards using TIBCO Spotfire, including cross tables, charts, and custom visualizations.
- Built information links, filters, bookmarks, and collaborative dashboards for clinical and safety reviews.
- Translated analytic specifications into actionable Spotfire visualizations and code, supporting CDS data requirements.
- Trainer and Mentor Role (Other process activities) -
- Served as Process Trainer for SDTM, SAS Programming, and QC, mentoring team members and improving skill development.
- Certified HR Associate Catalyst, contributing to the implementation and maintenance of SOPs and process improvements.
- Experienced in resource management, including preparing matrices, managing work allocation, tracking invoices, and overseeing team productivity.
- Ensured high-quality deliverables in line with Service Level Agreements (SLAs), maintaining client satisfaction and compliance standards.
Education
Master of Computer of Application -
IGNOU
Mumbai01.2022
Bachelor of Science - Computer Science
University of Mumbai
Mumbai01.2016
HSC -
JVM ‘s Mehta College
Navi Mumbai01.2013
Skills
- SDTM mapping specifications
- TDD creation
- CRF annotation
- Pinnacle 21 expertise
- Definexml proficiency
- SAS programming
- Domain mapping
- External data reconciliation
- R programming
- Study leadership
- Strategic planning
Disclaimer
I hereby declare that all the particulars given above are true to the best of my knowledge.
Personal Information
Title: Sr. Biostatistical Programmer
Certification
Global Base SAS Programming.
Timeline
Sr. Biostatistical Programmer
Premier Research
04.2025 - Current
Assistant Manager-Clinical Data Services
Accenture Solutions Pvt Ltd
02.2021 - 04.2025
Senior SAS Programmer
IQVIA RDS (India) Private Limited
09.2020 - 01.2021
Senior SAS Programmer
Tata Consultancy Services
01.2017 - 09.2020
Master of Computer of Application -
IGNOU
Bachelor of Science - Computer Science
University of Mumbai
HSC -
JVM ‘s Mehta College