Business Analyst/Business System Analyst

Must Have 10/10 Comm Skills

Title: Business Analyst/Business System Analyst

Start: ASAP

Locatio - (Hybrid) Cambridge MA – preference is for local candidates

Interview Process: 3 rounds

Candidates must be onsite 2nd week of every month for institute week – no exceptions – client will not pay for expenses so that is why local is preferable

Must Have

Strong Business Analyst background

Senior data person – data warehouse/data mapping – preference for data scientist

Life sciences – GXP background

SQL

Cloud platforms

Skills & Abilities

• Superior communication (verbal and written) and presentation skills with the ability to effectively advocate technical solutions and results to technology and business audiences.
• Must be able to effectively prioritize and plan; must have the ability to address multiple projects and adapt to changing priorities.
• Ability to work independently and collaboratively with cross-functional/inter-departmental teams and within the framework of the Enterprise Operations IT organization.
• Self-motivated and passionate to learn and adopt new technology and nimble, pragmatic methodologies. Must be able to deal with ambiguity, work through issues with agility but without compromise to best practice processes and documentation.
• Team-oriented and generous in sharing knowledge and enabling others.
• Strong communication and facilitation skills to lead teams to establish consensus, ensure clarity and decisions/justifications.
• Effective negotiation and persuasion skills to manage stakeholder expectations.
• Excellent time management and the ability to prioritize tasks effectively.
• Attention to detail in documenting requirements, creating reports, and managing project documentation.
• Creative and critical thinking skills to develop innovative solutions to business challenges.
  
  

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
  
  

Day To Day

• 50% of will be very technical and working with very technical teams. Candidates must know data infrastructure, data analytics, the cloud (AWS/Azure)
• 50% BA activities – gathering requirements, etc.
  
  

Ideal candidates will come from a Life sciences background (GxP) and be combination of BSA and senior data person. Candidates should know SQL and cloud platforms. The big thing here is being able to have technical conversations around data infrastructure, data lakes, system testing, etc. They will also work with 3rd party vendors and providing input to ideas for new applications.