IT Business Analyst, Clinical & Biostatistics

Responsibilities and Duties

Business Partnership & Process Improvement

• Build strong partnerships with Clinical Development, Clinical Operations, Clinical Data Management, Biostatistics, and Statistical Programming to understand business priorities, challenges, risks, and opportunities and serve as a technology subject-matter resource for assigned systems and processes.
• Conduct discovery through interviews, workshops, document analysis, task analysis, and data-flow reviews; translate needs into requirements, user stories, acceptance criteria, process maps, data mappings, and traceability artifacts.
• Map end-to-end clinical data flows from source acquisition through data review, reconciliation, standardization, analysis, reporting, and regulatory submission, and partner with business process owners to support future-state process design.
• Partner with stakeholders and the Director, IT Business Partner R&D to assess business demand, enhancements, and project opportunities and provide input into prioritization based on business value, risk, urgency, and available resources.
• Partner with study teams to anticipate and support technology and data needs across study startup, conduct, database lock, closeout, and submission readiness.

Solution Delivery & Application Management

• Support clinical trial systems and processes including EDC, eTMF, CTMS or trial tracking, eCOA or ePRO, IRT or randomization, laboratory and imaging data, clinical data repositories, and analytics.
• Support statistical computing capabilities and workflows, including validated workspaces, controlled code and metadata, data transfers, SDTM and ADaM production, TLF generation, outputs, archival, and reproducibility.
• Partner with business, vendors, and technical teams on platform configuration, study setup, integrations, secure transfers, APIs, data ingestion, reconciliation, dashboards, and downstream analytics readiness.
• Develop and maintain business cases, scope, requirements, operating models, RACI, process flows, data lineage, governance materials, support procedures, and roadmap inputs.
• Lead or coordinate test strategy, scripts, user acceptance testing, defect triage, validation evidence, release readiness, training, adoption, and transition to steady-state support for assigned initiatives.

Data Standards, Governance, & Compliance

• Support clinical data standards, metadata governance, and cross-study consistency in partnership with Clinical Data Management, Biostatistics, Statistical Programming, and other process owners.
• Ensure projects and changes follow applicable IT lifecycle, change control, validation, security, privacy, data integrity, records management, and GxP procedures.
• Coordinate application support, issue resolution, root-cause analysis, enhancement intake, release planning, and vendor performance for assigned clinical and biostatistics systems.
• Communicate dependencies, status, decisions, and risks to cross-functional teams and senior leadership.
• Contribute to the R&D technology roadmap and support the evaluation of automation, analytics, metadata-driven standards, and responsible AI opportunities across clinical data and statistical workflows.

Qualifications and Skills

• Bachelor’s degree in information systems, computer science, life sciences, or a related field, or equivalent practical experience.
• 5+ years of progressively responsible business analysis, product ownership, application management, or technology delivery experience in a life-sciences or biopharmaceutical environment.
• Experience supporting systems and processes used by clinical development, clinical operations, clinical data management, biostatistics, or statistical programming systems in a regulated life-sciences environment.
• Working knowledge of the clinical study lifecycle, including study startup, conduct, monitoring, data acquisition, data cleaning and review, reconciliation, database lock, closeout, and archival.
• Strong elicitation, process mapping, requirements, testing, documentation, analytical, facilitation, and stakeholder-management skills.
• Demonstrated ability to manage multiple priorities, work independently within established direction, influence outcomes, and contribute hands-on when needed.
• Excellent written and verbal communication skills with a strong customer service, technology advisory, and partnership mindset.
• Hands-on implementation or support of EDC, clinical data repository, eTMF, CTMS, or statistical computing platforms.
• Knowledge of GxP computerized system validation, 21 CFR Part 11, electronic records controls, audit readiness, and data integrity principles.
• Relevant business analysis, product ownership, project management, Agile, Veeva, or life-sciences technology certification.

Preferred Qualifications

• Experience implementing or supporting one or more of the following: EDC, clinical data repositories, eTMF, CTMS, eCOA/ePRO, IRT/RTSM, or validated statistical computing platforms
• Experience with platforms such as Medidata Rave or comparable EDC; eClinical Solutions elluminate or comparable clinical data repository and review platform
• Working knowledge of clinical data management workflows, external data transfers, edit checks, coding, issue management, and oversight of CRO or technology vendors
• Working knowledge of biostatistics and statistical programming workflows from analysis specifications through standardized datasets, tables, listings, figures, quality control, and submission deliverables.
• Working knowledge of CDISC SDTM and ADaM, TLF workflows, SAS, clinical data transfers, and database-lock processes.
• Experience with clinical data transfers using SFTP or APIs, integration and ETL patterns, metadata repositories, reporting tools, Microsoft 365, SharePoint, and Smartsheet.
• Experience managing CROs, SaaS vendors, implementation partners, support SLAs, releases, and enhancement backlogs.