LAIJU P THOMAS
Bangalore,India
Summary
An enthusiastic, confident, and reliable professional having 8 years of experience in Clinical SAS projects, right now looking for a position of Senior SAS Programmer in Pharmaceutical or related sectors with a reputed and exciting company.
Overview
9
9
years of professional experience
Work History
Senior Programmer Analyst II
Thermo Fisher Scientific
04.2023 - Current
- Acts as lead programmer or project lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets.
- Assumes leadership responsibility as a contributing member of a multidisciplinary project team, communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs.
- Independently creates, executes, maintains, and validates programs that transfer data across multiple data management systems or operating systems, combines data from a variety of sources and structures, generates and stores summary data from a variety of sources, generates reports or combines multiple databases and validates programs that generate listings, tables and figures using SAS.
- Manages and documents assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.
- Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.
- Provides training, guidance, and project leadership to junior team members.
- Provides general infrastructure support to the Department, including representing the company at industry conferences, presenting/teaching at department meetings, assisting in establishing training materials, and contributing to other general department documents or policies such as the development of departmental working practice documents and SOPs.
- Developed SAS programs to produce SDTM datasets and mapping specification based on the CDISC, SDTM implementation guide, CRF and other study documents.
- QC of SDTM domains and mapping specification based on SDTM IG, CRF and other study documents.
- CRF Annotation for the domains worked on SDTMs.
- Developed SAS programs to produce ADaM datasets and metadata based on the CDISC, ADaM implementation guide, Mock shell, other study documents and client specific documents.
- QC of ADaM domains and metadata based on ADaM IG, Mock shell, other study documents and client specific documents.
- Produced and validated safety and efficacy tables, listings, and figures.
- Developed and reviewed define .xml as part of submission activities.
- Assisted company with recruitment activities.
- Mentored junior staff to help them develop a career.
- As PPD specific macro SME, trained programmers to help develop the macro knowledge.
- Suggested and implemented a new process for running Patient Data Dashboard.
- Took presentations on PPD specific macros multiple times and also on Collapsing in ADaM Datasets. Developed a dynamic code for collapsing which could be re-used for collapsing per different levels.
Senior Programmer Analyst
Thermo Fisher Scientific
07.2021 - 03.2023
Senior Programmer
Quanticate India Ltd.
Bengaluru
10.2018 - 07.2021
- Develop SAS programs to produce SDTM datasets and mapping specification based on CDISC, SDTM implementation guide, CRF other study documents
- QC of SDTM domains and mapping specification based on SDTM IG, CRF and other study documents
- CRF Annotation for the domains worked on SDTMs
- Develop SAS programs to produce ADaM datasets and metadata based on the CDISC, ADaM implementation guide, Mock shell, other study documents and client specific documents
- QC of ADaM domains and metadata based on ADaM IG, Mock shell, other study documents and client specific documents
- Production and QC (Validation) of safety and efficacy tables, listings and figures
- Lead activities of studies (assignments, documentations, client interaction, …)
- Created logcheck macro to help improve the client process
- Worked on SDTM supplementary macros
- Received client appreciation multiple times for queries raised on efficacy analysis and SAP which helped to improve quality
- Received client appreciation for teamwork, dedication and hard work
- Helped in many studies when needed helping hand to resolve issues and find out issues with client specific macros
- Line Management (Had 3 people reporting - Helped them with their overall improvement)
- Assisted company with recruitment activities.
- Mentoring Juniors to help them develop career.
Programmer Analyst II
PPD
09.2018 - 04.2019
- Develop SAS programs to produce SDTM datasets based on the CDISC, SDTM implementation guide and mapping Specification
- QC of SDTM domains based on SDTM IG and mapping Specification
- Program data reports for data management team in support of their data cleaning process
- Performing data extraction from various repositories and pre-process data when applicable
- Production and QC (Validation) of safety and efficacy tables and listings
- QC (Validation) of figures
- Maintain documentation regarding project progress and programming updates and all other documentations as required on a regular basis
- Coordinating with study team and statisticians to ensure the smooth running of the study
- Familiar with conversion of SAS datasets to various file types as well as conversion of various file types to SAS datasets
- Headed different studies and handled different pressure situations
- Performed other programming tasks as necessary to support Clinical Data Management and Biostatistics
- Asses and ensured the validity of all program output
- Mentoring the junior programmers.
Programmer Analyst I
PPD
04.2017 - 03.2019
Associate Programmer Analyst
PPD
07.2015 - 03.2017
Education
Bachelor of Mathematics -
MG University
2012
Skills
- Total experience of 8 years as Clinical SAS programmer
- Good experience in CDISC and Non-CDISC projects
- Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines
- Creation of SDTM and ADaM Specification
- Development and QC of SDTM and ADaM datasets
- Development and QC of TLFs
- Annotation of CRF
- SDRG and ADRG creation and it's review
- Knowledge of P21 Community and Enterprise versions
- Define creation and review
- Worked on safety and efficacy datasets and outputs
- Ability to lead studies and communicate effectively with client
- Ability to proactively understand possible risks and escalate effectively
- Ability to deliver quality outputs/datasets, also give suggestions whenever needed
- Creation of general process macros to help company to have smooth processes
- Ability to understand situation and proactively work as team
- Majorly worked on Oncology studies and has good knowledge of RECIST 11 and oncology efficacy domains
Timeline
Senior Programmer Analyst II
Thermo Fisher Scientific
04.2023 - Current
Senior Programmer Analyst
Thermo Fisher Scientific
07.2021 - 03.2023
Senior Programmer
Quanticate India Ltd.
10.2018 - 07.2021
Programmer Analyst II
PPD
09.2018 - 04.2019
Programmer Analyst I
PPD
04.2017 - 03.2019
Associate Programmer Analyst
PPD
07.2015 - 03.2017
Bachelor of Mathematics -
MG University
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