IT Business Analyst, Clinical & Biostatistics

Boston, MA
Full Time
IT
Experienced
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.

Opportunity Overview
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.

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.
  • Parter 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.

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.

The expected salary range for this position is $90,000 - $135,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. 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.

More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.

At Rhythm our core values are:
  • We are committed to advancing scientific understanding to improve patients’ lives
  • We are inspired to tackle tough challenges and have the courage to ask bold questions
  • We are eager to learn and adapt
  • We believe collaboration and ownership are foundational for our success
  • We value the unique contribution each individual brings to furthering our mission

Inherent in our core values is the commitment to act ethically and with integrity in all we do.

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.


 
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