Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description

The Senior IT Business Analyst, GCP & Data Management Systems serves as a strategic IT partner to Wave’s Clinical Development organization, with responsibility for aligning technology capabilities, business processes, and clinical data solutions with business priorities and regulatory requirements. The role partners closely with Clinical Operations, Clinical Data Management, Biostatistics/Statistical Programming, Pharmacovigilance/Drug Safety, Clinical Quality Assurance, Regulatory Affairs, CROs, and technology vendors to identify business needs, improve processes, develop technology roadmaps, and deliver compliant and scalable solutions supporting clinical development.

The position provides leadership across the lifecycle of GCP computerized systems, including platforms supporting eTMF, clinical data, statistical programming, IRT/RTSM, safety, document collaboration, analytics, and system integrations. A key area of responsibility is helping lead Wave’s clinical data centralization strategy, establishing a governed and integrated clinical data foundation that consolidates information from CROs, vendors, laboratories, and internal systems to strengthen clinical oversight, analytics, decision making, and inspection readiness. This position is expected to operate with a high degree of independence, lead complex cross-functional initiatives, develop strategic plans and roadmaps, identify opportunities for enterprise process improvement, and serve as a trusted liaison between IT and business stakeholders.

Experience

Bachelor’s degree in Information Systems, Life Sciences, Data Science, Engineering, or a related discipline required; Master’s degree preferred
8+ years of progressive experience in information systems, business analysis, or technology delivery, preferably within biotechnology, pharmaceutical, or CRO environments
Demonstrated experience leading complex, cross-functional technology initiatives and translating business strategy and operational needs into technology roadmaps and solutions
Strong experience partnering with Clinical Operations, Clinical Data Management, Biostatistics/Statistical Programming, Drug Safety, Clinical QA, and related clinical development functions
Hands-on involvement implementing, supporting, or providing business ownership for GCP systems such as CTMS, eTMF, clinical data repositories/platforms, SAS/statistical programming environments, IRT/RTSM, safety systems, or similar clinical technologies
Experience with clinical data integration or centralization initiatives, including data ingestion, metadata management, data lineage, reconciliation, analytics, and integration of data from CROs and external vendors
Demonstrated experience leading business process analysis, fit/gap assessments, requirements definition, solution evaluation, and process improvement initiatives
Background supporting computerized system validation activities, including requirements, risk assessment, validation planning, testing, traceability, change control, and maintenance of validated state