IT Business Analyst, Clinical & Biostatistics

Rhythm Pharmaceuticals • Boston, MA

7d • $90,000 - $135,000 • Hybrid

About The Position

Reporting to the Director, IT Business Partner, R&D, this role will serve as the primary IT Business Analyst for Clinical and Biostatistics. The analyst will translate clinical development, clinical operations, data management, biostatistics, and statistical programming needs into scalable technology, data, and process solutions. The role will support clinical and statistical platforms from discovery and implementation through validation, adoption, integration, operational support, and continuous improvement. This role combines business partnership with hands-on business analysis, solution delivery, and application support, working closely with R&D stakeholders, Quality, IT colleagues, and external vendors.

Requirements

• 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.

Nice To Haves

• 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.
• Relevant business analysis, product ownership, project management, Agile, Veeva, or life-sciences technology certification.

Responsibilities

• 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.
• 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.
• 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.

Benefits

• A discretionary annual bonus may be available based on individual and company performance.
• This role may be eligible for benefits and other compensation such as restricted stock units.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level