Summary
Overview
Work History
Education
Skills
Websites
Timeline
Disclaimer
Generic

Tanuja Yadav

Bangalore

Summary

Results-oriented professional with over 8 years of experience consistently delivering high-quality work within tight deadlines. Strong analytical and problem-solving skills are complemented by effective communication abilities. Proven team player who fosters collaboration and guides colleagues while leading projects to drive successful outcomes. Committed to excellence and continuous improvement in all aspects of work.

Overview

9
9
years of professional experience

Work History

Senior SDTM Programmer

NOVO NORDISK
08.2022 - Current
  • Be compliant on SOPs, GCP, GDP and GPP.
  • Promote exchange pf known-how within the organization and externally via participation in meetings.
  • Ensure initial MMA setup is done as per the trial requirement.
  • Design the metadata specification and aCRF requirements.
  • Finalize SDTM (Study Data Tabulation Model) deliverables.
  • Working as a Lead across TA, regular QC and metadata updates.
  • Provide Business support.
  • Maintain process related documentation.
  • Review of CRFs Special attention should be given to non-standard modules. regarding impact on SDTM.
  • Request codes/topic codes as needed.
  • Perform custom programming on trial specific needs if required and validate according to relevant SOP.
  • Create and maintain aCRF (annotated Case Report Form) along with QC of aCRF.
  • Generate SDTM datasets and perform QC.
  • Ensure peer review of the mappings when generated out of Clinical Data Warehouse and validate custom programs used in the generation of SDTM datasets according to relevant SOP.
  • Create define.xml.
  • Create and maintain SDRG (Study Data Reviewer’s Guide).
  • Run Pinnacle 21 checks and resolve issues by coordinating with Trial Data Management, Clinical Data Programmer and Biostats community.
  • Finalize SDTM package and perform complete run-in alignment with Biostats.
  • Prepare contents for the package based on trial requirements and engage in interactions with Safety surveillance/external statistician

India Stat Programmer

IQVIA
08.2021 - 08.2022
  • Worked on Late phase and Early phase clinical trials, which included programming and mapping of the SDTM domains.
  • Understanding and implementing the datasets according to CDISC SDTM IG’s.
  • Was a part of COE team where handling the studies as sole programmer and study lead and had direct contacts with Study data managers.
  • Developing SAS programs for data analysis, data migration and data conversion.
  • Analysis of data, modification of data and creation of data according to FDA guidelines, done using SAS queries.
  • Understanding and complying with ICH-GCP guidelines.
  • Creating SDTM mapping specifications using the SDTM guidelines.
  • Review of CRFs and using annotated CRFs for creation of mapping specifications.
  • Creation of define.xml for submission data (SDTM) and validating it.
  • Using SDTM standards to create metadata creation using SDTM domains.
  • Done client interaction for fetching and resolving data issues, getting feasible data and other required documents like IFA, CRFs.
  • Creation of Pinnacle 21 reports and then using it for further analysis of datasets.
  • Creation of xpts of datasets to generate reports.
  • Direct interactions with data managers for vendor datasets.
  • Used SAS to generate tables, derived datasets in the statistical analysis plan and programming specifications.
  • Prepared internal meeting setup, contribute ideas, demonstrate respect for opinions of others
  • Completed project programming activities within timeframe allotted by Lead Statisticians.

STATISTICAL PROGRAMMER II

SYNEOS HEALTH
02.2020 - 08.2021
  • Worked on Late phase and Early phase clinical trials, which included programming and mapping of the SDTM domains.
  • Understanding and implementing the datasets according to CDISC SDTM IG’s.
  • Was a part of COE team where handling the studies as sole programmer and study lead and had direct contacts with Study data managers.
  • Developing SAS programs for data analysis, data migration and data conversion.
  • Analysis of data, modification of data and creation of data according to FDA guidelines, done using SAS queries.
  • Understanding and complying with ICH-GCP guidelines.
  • Creating SDTM mapping specifications using the SDTM guidelines.
  • Review of CRFs and using annotated CRFs for creation of mapping specifications.
  • Creation of define.xml for submission data (SDTM) and validating it.
  • Using SDTM standards to create metadata creation using SDTM domains.
  • Done client interaction for fetching and resolving data issues, getting feasible data and other required documents like IFA, CRFs.
  • Creation of Pinnacle 21 reports and then using it for further analysis of datasets.
  • Creation of xpts of datasets to generate reports.
  • Direct interactions with data managers for vendor datasets.
  • Used SAS to generate tables, derived datasets in the statistical analysis plan and programming specifications.
  • Prepared internal meeting setup, contribute ideas, demonstrate respect for opinions of others
  • Completed project programming activities within timeframe allotted by Lead Statisticians.

SOFTWARE ENGINEER

HCL TECHNOLOGIES
04.2016 - 02.2020
  • Reading, understanding, and implementing datasets according to SOPs, WIs, and relevant regulatory guidelines (eg - ICH).
  • Understanding and implementing the datasets according to CDISC SDTM IG’s.
  • Developing SAS programs for data analysis, data migration and data conversion.
  • Analysis of data using SQL queries.
  • Using SQL queries to retrieve data from database like SELECT, UPDATE, DELETE, CREATE TABLE, JOIN for analyzing and retrieving of data using SQL.
  • Analysis of data, modification of data and creation of data according to FDA guidelines, done using SAS queries.
  • Understanding and complying with ICH-GCP guidelines.
  • Creating SDTM mapping specifications using the SDTM guidelines.
  • Review of CRFs and using annotated CRFs for creation of mapping specifications.
  • Creation of define xml for submission data (SDTM) and validating it.
  • Using SDTM standards to create metadata creation using SDTM domains.
  • Done client interaction for fetching and resolving data issues, getting feasible data and other required documents like IFA, CRFs.
  • Worked on Data conversion from 3.1.2 to 3.1.3 SDTM format.
  • Worked on creating approval documents like DMF, MAF.
  • Worked on various studies like vaccines studies, oncology studies, and Alzheimer’s studies.
  • Have handled various studies individually; have handled all the processes from starting with data analysis to migration of data in SDTM formats.
  • Have handled a team for annotations and have trained them for doing crf annotations.
  • Worked in timely bound schedules with good quality output.
  • Worked on maintaining all supporting documentation for studies in accordance with SOP’s/ Guidelines.

Education

B.Tech - M.Tech Dual Degree - Biotechnology

JAYPEE INSTITUTE OF INFORMTION TECHNOLOGY
Noida
01.2015

Skills

  • Programming Languages: Base SAS, clinical SAS, SQL
  • Tools: SQL Developer, p21 pinnacle tool, DIASS (SAS based tool)
  • Knowledge of CDISC SDTM IG-31, 32 , 33
  • Knowledge of CDM (Clinical Data Management) processes
  • Knowledge of Good Clinical Practices

Timeline

Senior SDTM Programmer

NOVO NORDISK
08.2022 - Current

India Stat Programmer

IQVIA
08.2021 - 08.2022

STATISTICAL PROGRAMMER II

SYNEOS HEALTH
02.2020 - 08.2021

SOFTWARE ENGINEER

HCL TECHNOLOGIES
04.2016 - 02.2020

B.Tech - M.Tech Dual Degree - Biotechnology

JAYPEE INSTITUTE OF INFORMTION TECHNOLOGY

Disclaimer

I hereby certify that all the information provided here is correct to the best of my knowledge and belief. TANUJA YADAV

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Tanuja Yadav