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Business Systems Analyst

1 month ago

Boston, United States Saxon Global Full time

Title : Business Systems Analyst

Company: Bill & Melinda Gates MRI

Location: Remote mostly but then come onsite once a month for Institute week (2nd week a month) - must be local; One Kendall Square, Building 600, 3 RD FL, Cambridge, MA 02139

Duration: through the end of the year

Rate : $75/hr. on C2C

Visa : No H1

Must Haves:

  • 7+ years as a BSA - able to gather requirements, UAT, creating presentations and presenting, etc.
  • Experience in the pharma industry
  • Strong Agile
  • Strong technical knowledge and able to work with technical users
  • Understanding data pipelines and gathering heavy data requirements.

Required Technical Knowledge/Experience/Skills:
  • Strong understanding of agile concepts and certification in agile methodology
  • Strong understanding of modern data systems and tools including data platforms, data warehouses, data lakes, data ingestion, distribution pipelines, and data analytics/visualization how to apply this knowledge to clinical and real-world data.
  • Strong Pharma/Life Sciences experience with an in-depth understanding of Clinical Development and Operations processes
  • Strong understanding and working knowledge of:
    • GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, ICH E6(R2)
    • Clinical Trial Data (STDM, ADaM, DTD, eCTD/XML)
    • Nonclinical Study Data (SEND)
    • Safety Data (ISO/HL7 27953: E2B(r2), E2B(r3); ICSR, PADER, PSUR, DSUR)
  • Experience working in a Computer System Validation (CSV) process and SDLC process.
  • Understanding and experience with Pharma related Technology Solutions/Platforms, including but not limited to:
    • PV Safety Databases/Technologies, EDC Platforms, IRT Platforms, Document Management Technologies e.g. Veeva, CTMS Technologies, ePRO, etc.
  • Strong understanding and experience designing solutions and working in and Azure and AWS Cloud Environments
  • Understanding of software development processes and methodologies (e.g., Agile, Scrum, Waterfall, SDLC).
  • Certified and experienced in working within an agile framework e.g. SaFe and as part of an agile team.
  • Able to work within Jira and is proficient in creating and managing Epics, User Stories and Tasks.
  • Able to analyze complex data to identify trends, patterns, and insights utilizing modern IT tooling.
  • Any relevant certifications (e.g., CBAP, PMI-PBA) or formal training in business analysis and solution development
  • Proficiency in using analytical tools and software for data analysis.
  • Ability to troubleshoot issues and implement effective resolutions.
  • Understanding of technical IT issues to organize discussions with internal and external technical specialists. Must be able to ensure best practices are used for each type of technology infrastructure: client/server, virtual environments (private, AWS, Azure), single or multi-tenant web-based Software as a Service (SaaS) solutions.
Required Work Experience:
  • Advanced degree in computer science, technology, engineering, or related disciplines required.
  • 7+ years pharmaceutical/biotech company or consulting experience required.
  • Experience in clinical development.
  • Experience supporting heavily outsourced partner/vendor organizations including CROs/FSPs.
  • Experience working with and implementing data platforms and services.
  • Experience selecting, designing and implementing IT Applications
  • Experience working in both custom developed cloud-based solutions and "as a Service" solutions e.g. IaaS, SaaS, PaaS etc.
  • Experience defining data processes & standards and/or data integration mechanisms.
  • Experience leading regulated systems in a GxP regulated industry; Computer Software Validation (CSV), and IT SDLC