Shankar Giridhar Vijayakumar

Data Engineer at Pieris Pharmaceuticals
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Contact Information
us****@****om
(386) 825-5501
Location
Munich, Bavaria, Germany, DE
Languages
  • English Native or bilingual proficiency
  • Tamil Native or bilingual proficiency
  • German Elementary proficiency
Skills

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Credentials

  • SAS Certified Clinical Trials Programmer Using SAS 9
    SAS
    Apr, 2017
    - Nov, 2024
  • SAS Certified Advanced Programmer for SAS 9
    SAS
    Aug, 2015
    - Nov, 2024
  • SAS Certified Base Programmer for SAS 9
    SAS
    May, 2015
    - Nov, 2024

Experience

  • Pieris Pharmaceuticals
    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Data Engineer
      • Jan 2022 - Present

  • Zifo
    • United States
    • IT Services and IT Consulting
    • 700 & Above Employee
    • Lead Consultant
      • Apr 2021 - Dec 2021

      Lead Consultant | Lead Developer and Tester | Team, Technical Lead- Business process solutions | Technical solutions | Consultancy- Business process analysis- Development and validation | ELN, LIMS- Data-science and digitalization | Laboratory Automation- Data analysis and reporting | FAIR- Onsite and Remote- Project, Team management | Customer Success | Technical, Commercial Excellence

    • Business System Analyst
      • Sep 2019 - Mar 2021

      On-site Consultant | Developer | Tester | Team, Technical Lead- Business process solutions | Technical solutions | Consultancy- Requirement gathering, analysis, documentation | Business analysis | GDocP- Development and validation | ELN Template Factory | Inventory- Database and instrument integrations | ELN-EWB- Laboratory Digitalization | Automation | FAIR- Onsite and Remote- Project, Team management | Deliveries | Decisions | Impact analysis

    • Senior System Analyst
      • Jan 2018 - Sep 2019

      On-site technical co-ordinator | Developer | Tester- Training on features, functionalities and internals of systems such as ELN, LIMS etc.- Requirement gathering and analysis | Business analysis- Bioprocess solutions configuration | ELN-EWB | Inventory- Development and validation of ELN templates for various laboratory processes | Automation- Onsite project management and co-ordination | Impact analysis | Pre-clinical domain

    • Senior Programmer Analyst
      • Oct 2016 - Dec 2017

      Specification Designer | Developer | Tester | Team, Technical Lead- SDTM, ADaM specification design and dataset development | Protocol Analysis | SAS- Develop and debug Tables, Listings (Reports) and Graphs based on ICH guidelines | SAS- Development and validation | SAS macros- Specification library | eCRF | SDTM | ADaM- Program Library | SAS | SAS-SQL- Clinical Data Management and Visualization | Product Development | R | HTML | CSS- Customer interactions | Project, Team management | Process Solutions | SOPs

    • Programmer Analyst
      • May 2015 - Sep 2016

      Specification Designer | Developer | Tester- Design eCRF specification and develop EDC forms for various drugs across different portfolios | Protocol Analysis- Develop and debug Edit checks for several EDC products like Viedoc | JavaScript- Validation of Edit- and Manual- checks in EDC products | Test scripts | SAS- Design SDTM, ADaM specifications | Protocol Analysis- Develop and debug CDISC compliant SDTM, ADaM datasets | SAS- Validation of datasets | SAS-SQL- Customer interactions | Demos | Project management

    • Associate Analyst
      • May 2014 - Apr 2015

      Learning phase: Training on various topics- Company policies, SOPs, Processes, Guidelines - Drug discovery and Clinical Trial phases- Pharmaceutical data systems | ELN, EDC, EPRO, SAS- Industry GxP regulations, standards and best practices | EU Annex 11, 21 CFR Part 11, CDASH, SDTM, SEND, ADaM- Data Extract generation | Extract specification in Excel & SAS datasets- Analysis Dataset generation | Analysis specification in Excel & SAS datasets- Tables, Listings (Reports), Graphs generation | SAS Reports- CRF Query Generation | Javascript- Development activities with assistance

Education

  • Government College Of Technology, Coimbatore
    Bachelor of Technology (BTech), Industrial Biotechnology
    2010 - 2014
  • Carmel Garden Matriculation Higher Secondary School, Coimbatore
    High School
    1996 - 2010

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