Business Data Analyst, Senior

Responsibilities Leads, performs, and oversees data‑management activities for assigned Alzheimer’s disease and related dementias (AD/ADRD) clinical studies, supporting both in‑house and outsourced trial data. Evaluates, develops, and implements data‑management processes, procedures, and tools to meet evolving business and regulatory requirements. Collaborates closely with Biostatistics, Informatics, Clinical Project Management, Clinical Operations, Medical, Drug Safety/Pharmacovigilance (DSPV), Regulatory, Project Management, and other internal stakeholders to ensure delivery of high‑quality data for regulatory submissions, safety reporting, and scientific publications. Demonstrated experience leading and supporting AD/ADRD clinical studies, including early protocol review, eCRF and database design, and alignment with dose‑escalation and safety objectives. Demonstrated experience leading the development and management of AD/ADRD clinical‑trial databases that support complex trial designs and processes, including adaptive randomization (CAR, RAR, BAR), platform trials, decentralized trial models, biomarker‑informed screening and enrollment, and community‑based prescreening. Extensive hands‑on experience overseeing data‑management workflows for AD/ADRD studies, with particular focus on accelerated data cleaning, continuous safety‑data surveillance, and timely execution of recurrent analyses. Works closely with Clinical Project Management, Clinical Operations, Safety, Biostatistics, and Informatics teams to enable timely decision‑making and study‑governance processes in AD/ADRD trials. Performs hands‑on clinical data‑management activities to support clinical studies, including reviewing study protocols, designing eCRFs, coordinating and executing user‑acceptance testing (UAT), developing and documenting edit‑check specifications, quality‑controlling external data transfers, conducting data‑quality checks and discrepancy review, and ensuring timely completion of database‑lock activities. Participates in, reviews, and leads the development of policies, Standard Operating Procedures (SOPs), processes, and related documentation for data‑management activities; provides input on SOPs and processes involving data management. Promotes and advocates for data‑management practices in cross‑functional and departmental meetings. Provides domain‑specific technical guidance to personnel in Data Management, Biostatistics, Informatics and other functions, and leads the development and execution of both general and project‑specific training initiatives. Assists in responding to questions and findings from QA audits and ensures that Corrective Action Forms (CAFs) are addressed and closed out appropriately. Actively monitors and researches current industry trends in clinical data management and shares relevant insights with appropriate stakeholders. Recommends enhancements to existing data‑management practices and procedures, including identifying, proposing, and implementing solutions for technology‑related issues. Assists in developing standardized data‑management documents across studies and programs, including eCRFs and edit‑check specifications. Participates in selecting outsourcing vendors and reviewing data management sections of proposals, including scope of work; monitors budgets as appropriate. Coordinates data management timelines for individual projects and, as well as clinical programs, including database lock, DSMB meetings, data review meetings, and monitoring CRO performance of data management tasks to ensure that timelines are met and that any resource issues are identified and resolved. Monitors in‑house clinical data management resources of assigned projects and identifies potential deficiencies; works with supervisor to develop and implement a plan to overcome any obstacles. Ensures that appropriate quality control checks and audit procedures are implemented according to department SOPs. Runs data review listings, issues queries, ensures medical coding is timely. Collaborates with database programmer to ensure ATRI data standards, including CDISC/SDTM, are followed for both in‑house and, if appropriate, outsourced projects. Identifies areas of risk and proactively communicates issues and solutions to supervisor and/or appropriate colleagues and team members. Actively participates in data management‑related NDA submission activities, as appropriate. Provides feedback, as requested, for performance evaluations. Identifies strengths and areas for improvement for CDM team members and works with supervisor to create a plan to develop team members. Works to improve tools and processes within functional area. Has the ability to work as part of and lead multiple teams. Performs other duties as assigned. Exhibits enthusiasm for working in a hybrid schedule (at least 60 percent onsite) and for interacting with stakeholders and peers in person. Requirements Bachelor’s Degree in Science, Technology, Engineering, or Medici