Suneeta Saranu

Work History

Head of SDTM Operations

Bristol-Myers Squibb (BMS)

05.2022 - Current

SDTM Standards Development: Collaborated with clinical data standards organizations to create CDISC-SDTM standards within MDR, ensuring compliance and consistency in adoption
Legacy Studies Standardization: Successfully guided SDTM transformation for legacy studies brought over during acquisitions and mergers
ECRT Package Submission: Led the generation and submission of eCRT packages (aCRF, define.xml, SDRG) to health authorities for entire BMS in-house portfolio
Innovation Initiatives: Spearheaded the exploration of semi-automated SDTM generation using MDR technology, currently in the adoption phase
Validation Strategy: Defined robust validation strategies to ensure SDTM compliance and audit readiness
Process Optimization: Streamlined various processes across data management and programming including but not limited to sponsor blinding, masking, protocol deviations dataflow and PK process
Team Leadership and Resource Management: Built and motivated cross-functional teams across different time zones, fostering collaboration and productivity
Budget Management: Striking a delicate balance between resource allocation, technology integration, and standardization while carefully evaluating the trade-offs between short-term gains and long-term advantages—within the context of budgetary limitations—is a facet that deeply resonates with my professional drive.

Senior Manager/Standards Steward, Global Biometrics and Data Standards

Heritage Celgene/BMS

06.2021 - 04.2022

SDTM Standards Leadership: Played a leadership role in CDISC SDTM standards development across different therapeutic areas including Oncology, Immunology, Cardiovascular and Hematology through cross-functional collaboration, ensuring seamless implementation within the programming organization
Training and Support: Provided guidance and training to in-house programming teams and CRO partners on BMS standards updates
Process Enhancement: Led process improvement initiatives within the SDTM function, optimizing efficiency and quality
Real-World Data Collaboration: Collaborated with CDISC standards organization to pioneer real-world data standards development both within and beyond the organization.

Senior Manager, Clinical SDTM Programming

Heritage Celgene/BMS

05.2019 - 05.2021

Strategic Leadership: Managed SDTM operations for Early Development studies, including workload planning, resource allocation, and quality oversight of CRO partners
Cross-Functional Collaboration: Served as the point of contact for project-specific issues arising from interactions across functions
ECRT Package Preparation: Oversaw the preparation and submission of eCRT packages (aCRF, define.xml, SDRG) to health authorities
Process Optimization: Identified areas for improvement and optimized existing processes
Team Empowerment: Energized team members during meetings, fostering active participation and excellence
Study Conductance: Assumed study conduct responsibilities, staying informed about processes and acting as a backup during resource constraints.

Lead Compound Data Information Specialist

Bayer Healthcare

01.2010 - 05.2019

Data Standards Upgrade: I received accolades and awards from senior management and team members for upgrading data standards
This involved transitioning from legacy formats to the CDISC (Clinical Data Interchange Standards Consortium) format
Project Submissions: Under tight timelines, I worked on developing SDTM mapping specifications from legacy standards
I also validated and submitted packages within the stipulated timeframes
These submissions were crucial for regulatory approval of drugs like JIVI and KOVALTRY
Collaboration and Maintenance: I collaborated with the Project Manager, Medical Expert, and Statistician
Together, we maintained therapeutic area and project standard library packages
These packages included SDTM datasets, annotated CRFs (Case Report Forms), metadata, format catalogs, and edit checks
Acquisition Databases: I built acquisition databases using raw data from sources like RAVE and external transfers
These databases were essential for statistical analysis
Vendor Oversight: I ensured quality assurance for outsourced studies by overseeing data quality checks
When issues arose, I directed the output to the appropriate team
External Data Integration: I developed Electronic Data Transfer Specifications for external data sources such as Labs, ePRO, and PK
Additionally, I proposed process improvements for integrating external data into internal databases, which were successfully implemented
Medical Review Plan (MRP): In collaboration with Medical Experts, I created the initial draft objects and Patient Profiles in JReview for the Kogenate Compound
My commitment to teamwork, adherence to timelines, and contributions to data quality were recognized throughout my tenure
If you’d like to see the awards, feel free to request them!

Clinical Data Management Analyst

Astrazeneca

07.2007 - 12.2008

Edit-Check Programs: I developed edit-check programs and utilized company macros to identify discrepancies in raw data
Cleaning up the SAS datasets was a key part of this process
Study-Specific Documentation: I prepared test data and created study-specific “Ranges and Constants” and “Specification” documents for programming edit checks
SAS Datasets Creation: Using tools like the SAS import wizard, data step programming, and Dynamic Data Exchange (DDE) feature, I generated SAS datasets from raw data sources such as CVS, ASCII, and Excel
Data Validation: I performed data validation and reviewed SAS programs written by other coders to ensure accuracy
Transport Files: I created transport files using proc CPORT and proc CIMPORT
Format Catalogs: When necessary, I developed format catalogs
Cross-Platform Data Transfers: I managed data transfers between Windows and UNIX environments
Ad-Hoc SAS Programming: As needed, I conducted ad-hoc SAS programming for data listings, summary tables, and statistical analysis, supporting data management staff
Coding Standardization: I applied MEDdra and WHO Drug coded terms to dictionary modules (e.g., adverse events, medical history, surgical history, medication, and death) during data transfers under RAVE
This helped prevent redundant coding by coders
Coding Consistency Reports: I programmed and ran coding consistency reports
User Acceptance Testing (UAT): I participated in UAT for the coding process at the data management programmer end
AE and SAE Reconciliation: I handled adverse events (AE) and serious adverse events (SAE) reconciliation
Third-Party Vendor Collaboration: I contributed to preparing transmission plans from third-party vendors such as Covance, Clinphone, Icophone, and Perceptive for lab data
Data Conversion and Mapping: I was responsible for converting and mapping different formats of TPV data (e.g., hematology, urinalysis, PK, and diary data) to meet company standards
Third-Party Vendor Reports: Additionally, I created summary, reconciliation, and edit check reports for third-party vendor data, ensuring efficient query resolution.
Data Review Objects: created data review objects and patient profiles within JReview for medical experts.

Research Associate

University of Delaware

07.2003 - 04.2006

During my tenure as a Research Associate at the University of Delaware, I worked in a Psychology Lab, investigating the impact of memory drugs on protein and gene expression using techniques such as PCR, ELISA, Microarray Analysis etc.
By analyzing protein levels, we gained insights into cellular responses influenced by memory drugs

Summary

Overview

Work History

Head of SDTM Operations

Senior Manager/Standards Steward, Global Biometrics and Data Standards

Senior Manager, Clinical SDTM Programming

Lead Compound Data Information Specialist

Clinical Data Management Analyst

Research Associate

Education

Biotechnology (MS) -

Skills

Timeline

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