Summary
Overview
Work History
Education
Skills
Languages
Professionalmembershipscertifications
Personal Information
Disclaimer
Certification
Timeline
Generic

Veena Mohan Rao

Bangalore

Summary

With over 16 years of experience in clinical research industry, bringing a profound expertise in SAS and Clinical data programming/analysis that aligns well with the responsibilities outlined for the role. Career accomplishments include enhancing data management systems, standardize the process, and mentoring programming teams to achieve strategic bio-pharmaceutical objectives. Innovative professional with proven track record of developing solutions. Adept in multiple programming languages and offers great task prioritization and organizational skills. Proven ability to troubleshoot complex programming problems.

Overview

17
17
years of professional experience
1
1
Certification

Work History

Senior Statistical Programmer

IQVIA RDS India Private Limited
10.2020 - Current
  • Designed and programmed for statistical analysis strategies for Phase I, II and III clinical trials (including SDTM, ADAM datasets, FIRs and TFLs) in various therapeutic areas, utilizing SAS and R.
  • Programmed Tables, Figures and Listings (TFLs) in accordance with the Protocol and Statistical Analysis Plan (SAP).
  • Developed innovative statistical programming macros, which enhanced the reduction of overall timelines of program/dataset development. Implemented defensive programming techniques as a part of development lifecycle management of macros/programs/tools.
  • Developed Define xml and programming specifications for SDTM datasets, analysis datasets, pooled datasets, and deliverables in consultation with statistician.
  • Contributed to centralized program/code repository, which enhanced the re-usability of programs and aided in standardization of common safety/efficacy datasets.
  • Collaborated with biostatistician, data manager, medical writer, and other clinical , and project management team to meet ad-hoc project deliverables requirements, and timelines for clinical dataset development, and reporting.
  • Contributed to the Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Clinical Study Report (CSR), and Study Data Reviewers Guide (SDRG).
  • Mentored 10+ junior programmers, uplifting the team's technical capability and productivity.
  • Supported QA and client audits and adhered to documentation requirement as defined in SOP.

Clinical Data Standards Specialist

IQVIA RDS India Private Limited (GCE Solutions)
03.2018 - 04.2020
  • Involved in development, validation, and review of study, and standard programs/macros (Including SAS, R-Programming) that support standard and study-level conversion of clinical trial data.
  • Took responsibility for review, development, and validation of SDTM mapping, aCRF, SDRG (Study Data Reviewers Guide), Pinnacle 21, Define.xml, data Listings and checks for various standard or specific studies.
  • Lead requirement gathering, development of specifications, validation plans and performing end to end validation of Standard/Study macros.
  • Implemented defensive programming techniques as part of development lifecycle management of macros/ programs/ tools.
  • Managed end to end clinical trials (Clinical data management to submission) and ensured deliverables are met within stipulated timeline.
  • Supported programmers in troubleshooting and debugging of complex standard and study programs/ macros.
  • Acted as technical owner and/or reviewer/approver for tools and programs developed in group. For complex programs and tools, overseen and coordinated group of programming in matrix setting.
  • Establish and maintain effective working relationships with partners and stakeholders while assisting them through progress and challenges with deliverables.
  • Adhere to relevant departmental SOPs (Standard Operating Procedures), corporate policies, regulatory requirements, and industry best practices.
  • Adhere to CDISC standards and aware of industry standards and updates.

Associate Clinical Data Manager

IQVIA RDS India Private Limited
09.2014 - 02.2018
  • Design eCRF, per protocol requirement using iMedidata RAVE application, in adherence to CDISC - Clinical Data Acquisition Standards Harmonization (CDASH) guidelines.
  • Develop SDTM annotations and create bookmark as per submission requirements.
  • Developed edit check specification as per protocol need, and ensured that major/minor protocol deviation criteria are covered in edit checks.
  • Collaborated with data managers, statistical programmer and validation team to enhance quality data collection and timely deliverables of specifications and submission outputs.
  • Provided cross-functional training sessions on monthly basis on protocol interpretation and identification of major/minor protocol deviations.
  • Managed junior team of 6 members and provided technical guidance in case report forms development and timely deliverables of projects.
  • Contributed to, and maintained, centralized repository of edit check specification and programs.
  • Contributed to job aid and SOP guideline documents.

Statistical Programming Analyst

Accenture Services Private Limited
02.2013 - 08.2014
  • Developed Trial design datasets (TDM) , and Exposure dataset (EX), by utilizing SAS programming language, per protocol need.
  • Contributed to overall reduction of dataset development timelines by developing macro utilizing SAS program.
  • Provided input for eCRF designs from statistical point of view during setup phase of clinical trials for accurate data collection.
  • Reviewed statistical analysis plan (SAP), eCRF and provided input on project documentation and guidance on dataset development.
  • Performed developer testing, user acceptance testing (UAT) and independent programmer testing of SDTM datasets utilizing SAS program.
  • Responsible for review, development, and validation of SDTM mapping, aCRF, SDRG (Study Data Reviewers Guide), Pinnacle 21, define.xml, data Listings and checks for various standard or specific studies.
  • Worked with Biostatisticians, Clinical and Data Management team to ensure readiness of data for analysis and reporting.
  • Mentored junior statistical programmers, uplifting team's technical capabilities and productivity.
  • Executed Pinnacle 21 report and implemented fixes to code to resolve discrepancies.

Technical Designer

Accenture Services Private Limited
09.2010 - 01.2013
  • Managed clinical data process for 8+ clinical trials, ensuring 100% data accuracy and timelines.
  • Created and validated electronic case report forms(eCRFs), reducing data entry error, improving data quality.
  • Create SDTM Mapping Specification, SDTM annotations, aCRF Bookmarks and Define XML for eCRFs.
  • Collaborated with study lead, biostatistician, statistical programmers, and other project team members to ensure regulatory submissions were made on time and with 100% quality.
  • Contributed to centralized repository of SDTM specifications, annotations and global metadata.
  • Utilized Oracle clinical and Oracle Inform to facilitate data capture and entry.

SDTM Mapping Programmer

Accenture Services Private Limited
05.2007 - 08.2010
  • Provided SAS and PL/SQL programming expertise for Phase I and Phase II clinical trials.
  • Implemented automated data checks that reduced error rates in datasets.
  • Developed SDTM specification, Define xml, Annotated CRFs and reviewers guides to support data monitoring committee reviews.
  • Contributed to centralized programming repository by developing programs utilizing PL/SQL for purpose of re-usability.
  • Conducted knowledge sharing/lesson learnt sessions on quarterly basis to share solutions for programming issues faced by fellow programmers.
  • Participated in cross-functional project meetings and effectively communicated technical issues and their resolutions.

Education

Post Graduate Diploma in Data science - Data Science

International Institute of Informational Technology-Bangalore
Bengaluru, India
01.2021

Bachelor of Science (Computer Science) -

Mangalore University
Mangalore, Karnataka, India
04.2007

Skills

  • SAS and R programming
  • SQL and PL/SQL
  • Python
  • CDISC - CDASH, SDTM, ADAM and TFLs
  • SDTM Annotations and Bookmarking
  • iMedidata Rave and Inform EDC applications
  • Define xml (11 CRT package) and Pinnacle 21
  • Microsoft Office applications - Excel, Powerpoint and Word
  • Assertive communications and Effective problem solving
  • UNIX (Basic)

Languages

English
Advanced (C1)
Kannada
Bilingual or Proficient (C2)
Hindi
Advanced (C1)
Tamil
Bilingual or Proficient (C2)

Professionalmembershipscertifications

  • Certified Clinical Trial SAS Programmer, 12/2019
  • Medidata Rave Certified Study Builder, 01/2018
  • Base SAS 9.0 Certified, 02/2014

Personal Information

  • Date of Birth: 05/31/87
  • Gender: Female
  • Nationality: Indian
  • Marital Status: Married

Disclaimer

I hereby declare that I have reviewed the information contained in this curriculum vitae and that it is complete and truthful.

Certification

  • Certified Clinical SAS Programmer (December 2019)
  • Medidata Rave Certified Study Builder (17th January 2018)
  • Base SAS 9.0 Certified (23rd February 2014)

Timeline

Senior Statistical Programmer

IQVIA RDS India Private Limited
10.2020 - Current

Clinical Data Standards Specialist

IQVIA RDS India Private Limited (GCE Solutions)
03.2018 - 04.2020

Associate Clinical Data Manager

IQVIA RDS India Private Limited
09.2014 - 02.2018

Statistical Programming Analyst

Accenture Services Private Limited
02.2013 - 08.2014

Technical Designer

Accenture Services Private Limited
09.2010 - 01.2013

SDTM Mapping Programmer

Accenture Services Private Limited
05.2007 - 08.2010

Post Graduate Diploma in Data science - Data Science

International Institute of Informational Technology-Bangalore

Bachelor of Science (Computer Science) -

Mangalore University

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Veena Mohan Rao