* Seasoned Clinical Trial Analytics, Data Warehouse and Product development professional with hands-on experience in delivery of professional services in the area of clinical trial data management.
* Diverse consulting experience from working with over 50+ Pharma companies spanning over 100+ projects.
* Experienced in managing professional services teams specializing in Report Development, SDTM data standardization, Database design & management, SQL Programming, SAS Programming, EDC builds, Training, and Dashboard development in web based analytics platforms.
* Handled multiple roles in the Contract Research Organization (CRO) business spanning from business analyst, developer, trainer, technical lead, database architect, project manager and roles which required hands-on QA/QC experience.
* Expert in conceptualization and implementation of Visual Analytics, Business Intelligence and Operational Dashboards.
* Expert in clinical data standards (CDASH, SDTM & ADaM) and successful implementation of data models to support traditional SAS programming efforts, data repositories, Business Intelligence and web based analytics platforms.
Microsoft certified SQL Developer | SAS Certified Advanced SAS professional | Integrated Clinical System (ICS) certified JReview developer | Tibco Certified Spotfire Author | Pragmatic Marketing certified
Product Manager, Clinical @ At PerkinElmer, we are passionate about building solutions which enable Holistic clinical and operational data review for Clinical Review, Pharmacovigilance/Drug Safety, Clinical Trial Operations(including Risk Based Monitoring) Outcomes Research and Portfolio/Resource Management.
Delighting the scientific user is in the core of our DNA, bringing the scientific user closer to the data, enabling them with industry standard workflows in achieving the pro-activity in performing their activities yet abstracting them from the complexity of the source systems and their setup is my daily task at hand.
How we do it is not by building parts that make the whole but designing the whole and building the parts for it... From July 2015 to Present (6 months) Principal Software Specialist, Analytics @ I work at the intersection of Analytics and Clinical/Translational sciences:
* Delivering Services in the Clinical/Pharma sectors revolving around TIBCO Spotfire
* Developing Products in the areas of Data Surveillance, Clinical Data Review, Risk Based Monitoring, Outcomes, Pharmacovigilence and Drug Safety
* Building Visual Analytics and custom solutions for multiple functional areas such as Clinical Scientists, Medical Monitors, Data Managers, BI/SAS Programmers and Biostatisticians From March 2014 to June 2015 (1 year 4 months) Principal Technical Consultant @ As Principal Technical Consultant, I work closely with clients and provide high level consulting services and oversight for projects that include:
* Clinical Trial data standardization (SDTM & ADaM) programming using multiple programming languages
* Custom reporting across multiple BI Environments including JReview, Business Objects and SAS BI
* Clinical SAS Programming
* Training needs assessment, develop and deliver training content
* EDC Study builds
* Assessing new technologies
* Process improvements
* System validation
* SOP development
* Product Development (clinical software implementations and integrations)
* Project management
I am also responsible for managing delivery resources and assure that all client work has met or exceeded client expectations and predetermined profitability levels. From January 2013 to March 2014 (1 year 3 months) Sr. Technical Developer @ Developed CDISC SDTM based databases for supporting various Business Intelligence applications [eGrex - in house product, JReview - a third party BI application], developed analytics, reports in multiple BI environments, Project Management including but not limited to resource management, timeline and delivery schedules and developer mentoring. Managed and liaised with off-shore and local development teams. From May 2011 to January 2013 (1 year 9 months) SAS Programmer @ We mapped eCRF data to 100% CDISC compliant analysis datasets. I was involved in Kick-off, design, Programming and QC strategy design. From February 2011 to May 2011 (4 months) New London/Norwich, Connecticut AreaSAS Programmer @ Involved in an immersive end-to-end, CRF-to-Submission, clinical trial setup. Including study design, setup, programming analysis friendly datasets and support during post-submission, adhering to FDA (with 21 Code of Federal Regulations (21CFR) Part 11) and ICH regulations, using client proprietary reporting software (CDARS) and SAS.
• Extracted data from client’s OC based repository and ARGUS (Safety data warehouse) databases to build raw datasets, troubleshot a wide range of issues that involved database timeouts/ connection errors.
• Have developed reports, supporting Data Monitoring committees & Interim Analyses committees, of the trial at different stages (Phase II, II b, Post market safety) in Excel, CSV, RTF, HTML and PDF file formats using SAS/ODS From April 2010 to May 2011 (1 year 2 months) New London/Norwich, Connecticut AreaProgrammer Analyst @ Data warehouse and BI Consultant From March 2008 to 2011 (3 years) Burlington, Vermont AreaTechnical Developer @ Played a key role in designing, implementing best- approaches for this custom reporting project, managed the constantly changing reporting environment across three operating systems effectively, with a focus on delivering quality work under aggressive timelines
• Developed, tested and deployed various reports in IReview / JReview / SAS(Clinical) / SAS BI , which were based on a mix of databases: OC [both paper trials & RDC] , SQL SERVER [based on Medidata Rave] From November 2008 to March 2010 (1 year 5 months) Technical Developer @ We successfully developed and deployed enterprise – wide, across-study standard safety reports for all active studies (over 200 clinical studies) with minimal error rate and on-time delivery, on an industry-leading reporting application[IReview]
• Data analysis and report requirement gathering
• Develop, QC and deploy various reports which include: Adverse Event reporting, Patient profile configurations, Graphic Profile Creation From June 2008 to November 2008 (6 months)
MS, Computer Science @ New Jersey Institute of TechnologyBachelors of Engineering, Electronics & Communication @ Osmania University Chandi Kodthiwada is skilled in: Product Management, Spotfire, CDISC, EDC, SAS, 21 CFR Part 11, Oracle, Clinical Trials, SQL, SDTM, Data Warehousing, Microsoft SQL Server, Business Intelligence, Oracle Clinical, Database Design
Websites:
http://chandi.me,
http://www.perkinelmer.com/clinical-development-analytics