• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR. • Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required. • May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report. • Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department. • Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. • Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis. • Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications. • Implements company objectives, and create alternative solutions to address business and operational challenges. • Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. • Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. • Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management. • Provides statistical programming support as needed. • May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician. • May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. • Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness. • Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. • Coaches and mentors other Biostatistics staff. • Performs other work-related duties as assigned. • Minimal travel may be required.

• Execute and coordinate decentralized, fully remote clinical research activities across autoimmune studies. • Own day-to‑day remote member operations—from recruitment and e‑consent to virtual follow‑up and remote data collection. • Ensure protocol adherence and high‑quality real‑world data. • Monitor protocol adherence and visit windows using remote tracking tools; document adverse events and concomitant medications based on member reports and records. • Maintain accurate and complete electronic study documentation, including source notes, case report forms, and digital regulatory binders. • Support IRB submissions, amendments, and continuing reviews with remotely managed documents, reports, and member‑facing materials. • Collaborate virtually with data, product, and operations teams to troubleshoot remote workflows and ensure data quality in decentralized studies.

• Support Medical Monitor or serve as clinical lead of a phase 1a/1b study and future late-stage studies, including contributing to/overseeing study start-up, enrollment, study medical monitoring, data cleaning, and CSR writing • Partner with investigators and CROs to design and implement clinical studies, respectively • Write protocols, investigator brochures, and clinical study reports, and review clinical trial documents • Conduct investigator meetings and safety review committee meetings and lead site initiation visits with clinical trial investigators • Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets • Translate findings from research and non-clinical studies into clinical development opportunities • Interact with clinical investigators and thought leaders • Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines.

• Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, Biostatistics, and Regulatory Affairs, to design scientifically rigorous late stage clinical trials. • Contribute to the development of study protocols, investigator brochures, informed consent forms, and other essential study documents. • Provide scientific input for trial endpoints, patient populations, and statistical analyses. • Act as the scientific lead for assigned late stage studies, ensuring adherence to clinical trial protocols and regulatory requirements. • Provide ongoing scientific and clinical input during trial execution, including participation in investigator meetings, site initiation visits, study monitoring activities, and medical data review. • Review and interpret clinical trial data, ensuring consistency and alignment with study objectives. • Address protocol-related questions from investigators and site staff. • Contribute to the preparation of regulatory submissions, including clinical study reports (CSRs) and documentation for Investigational New Drug (IND) and New Drug Application (NDA) filings. • Ensure clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory standards. • Collaborate with the Biostatistics and Data Management teams to review and interpret study data, ensuring accuracy and completeness. • Participate in the preparation of abstracts, presentations, clinical study reports, and manuscripts for scientific meetings and publications. • Partner with cross functional team members to develop and execute clinical development strategies. • Serve as a subject matter expert within the clinical team, providing scientific insights to support decision-making.