Shubha Lakshmi
Bengaluru
Summary
Statistical programming professional with robust 8 years of experience in programming with track record of delivering quality output on time. Strong emphasis on team collaboration, reliability, and adaptability to evolving project requirements. Proven success in leading projects from start to finish and contributing to organizational growth and success.
Overview
14
14
years of professional experience
Work History
Principal Statistical Programmer
Fortrea
10.2024 - Current
- Perform the role of lead statistical programmer
- Plan, execute and oversee programming activities on a study, including but not limited to resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and clients, etc
- Develop and maintain SAS programs to the create SDTMs, ADaMs and TFLs and perform QC of the datasets and TFLs
- Produce the define XML, aCRF and reviewer’s guides to support SDTMs and ADaMs
- Develop or lead the development of the complex SDTM & ADaMs specifications in support of SAP and contributed to the development of organization and client standards
- Review the SAP, TFL mock shells from a programming perspective for studies and advice on development of the complex TFLs
- Mentoring activities for less-experienced programmers in process around the SDTMs/ADaMs and TFLs ensuring adherence to departmental processes and practices
- Respond to QA and client audits and support qualifying audits
- Contribute to proposal activities and participate in bid defense meetings
- Continually identify and suggest ways to improve the efficacy, quality and productivity of statistical programming
Senior Statistical Programmer
Fortrea
09.2021 - 09.2024
Statistical Programmer II
Lapcorp
11.2019 - 08.2021
Statistical Programmer I
Covance
02.2018 - 10.2019
Statistical Analyst
GSK
02.2017 - 01.2018
- DB Documentation: gather & analyze the functional requirements provided by the stakeholders for mentioned studies
Master Curator
Biobase
04.2012 - 10.2015
- To identify the possible DNA/RNA/protein target for various diseases
- To validate the junior’s curation work
Information Analyst
Informatics
08.2010 - 10.2011
- To maintain the database for the publications made by scientists from IASc
Education
Masters - Bioinformatics
Kuvempu University
01.2010
Skills
- Statistical Packages: SAS/Base, SAS/Macro, SAS/SQL, SAS/ODS, SAS/Graphs
- Operating systems: Windows
- Office Packages: MS Office
Disclaimer
I hereby declare that the above mentioned information is true & concerned documents will be submitted whenever needed.
Place: Bengaluru Shubha Lakshmi. K
SYNOPSIS:
- Overall 12 years of experience inclusive of 8 years of experience in clinical SAS programming.
- Having good understanding of SOPs/Clinical Protocols/SAP/Mock shells/CRF/Annotated CRF's and CDISC, SDTM/ADaM guidelines
- Good analytical, problem solving skills combined with the ability to work independently or in a team and always supporting team members during the requirements or in ad-hoc situations are my assets.
- Presented in knowledge sharing sessions at the departmental level.
- Interviewed a lot many people for selecting the exceptional talent across the industry.
Timeline
Principal Statistical Programmer
Fortrea
10.2024 - Current
Senior Statistical Programmer
Fortrea
09.2021 - 09.2024
Statistical Programmer II
Lapcorp
11.2019 - 08.2021
Statistical Programmer I
Covance
02.2018 - 10.2019
Statistical Analyst
GSK
02.2017 - 01.2018
Master Curator
Biobase
04.2012 - 10.2015
Information Analyst
Informatics
08.2010 - 10.2011
Masters - Bioinformatics
Kuvempu University
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