• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. • Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel. • Directs the activities of other biostatistics 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. • Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR. • Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required. • May be responsible as Lead Biostatician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report. • 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. • Implements company objectives, and creates alternative solutions to address business and operational challenges. • As biostatistics representative on project teams, interfaces with other departmental project team representatives • Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. • Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications. • May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. • Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics 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 escalates to management. • Provides statistical programming support as needed. • May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs. • Provides input and reviews, and subsequently 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. • Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. • Performs other work-related duties as assigned.

• Accountable for ensuring top-quality end-to-end trial delivery at a country level. • Managing the consistency of Local Trial Management duties and processes. • Serving as the country-level single point of contact on the study for internal partners. • Managing and overseeing Central IRB and other local vendors including set up of vendor purchase orders, invoice review and approval, and change-orders. • Execution of local milestones from feasibility through study close out. • Resourcing of country-level roles, including support with transitions. • Inspection Readiness and AQR at the country level. • Close collaboration with assigned Local Trial Managers, Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers. • Efficient communication with Clinical Trial Managers and Global Trial Leader to oversee trial excellence. • Conducting country level ad hoc meetings during any phase of the study to address unexpected circumstances.

Assistant Clinical Research Coordinator Location: Stanford United States Job Description: The Department of Radiation Oncology is hiring Assistant Clinical Research Coordinators to support the clinical research of several faculty physicians. This is a unique opportunity to receive mentorship from faculty on the cutting edge of radiation oncology, work closely with research teams to produce world-class clinical research, and gain insight into academic medicine. The Assistant Clinical Research Coordinator will perform administrative support duties related to the collection of clinical data and/or the coordination of clinical studies. General administrative support for the faculty, including managing calendars, scheduling meetings, and answering phone calls, is also required. The Assistant Clinical Research Coordinator will work under the direction and supervision of the faculty physicians, radiation therapy division manager, and clinical research manager. Stanford University, located between San Francisco and San Jose in the heart of California's Silicon Valley, is one of the world's leading teaching and research universities. Since its opening in 1891, Stanford has been dedicated to finding solutions to big challenges and to preparing students for leadership in a complex world. Supporting that mission is a staff of more than 10,000, which is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends and benefits that increase financial stability and promote healthy, fulfilling lives. An award- winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers. Duties include: Research Duties (50%): - Collect patient information by reviewing electronic medical records and organize data for analysis in retrospective research studies. - Interface with patients in order to administer research questionnaires. - Perform telephone or in-person interviews to gather data. Call patients for consents, reminders, or other requirements. - Correspond with the Institution Review Board and the SCI Clinical Trials Office in order to open, close, and renew research studies, register new patients consented for clinical studies, and assist adverse event and case report forms. - Perform clerical duties in the preparation of regulatory documents. Maintain all forms and documents, including consent forms and master subject logs. File all appropriate correspondence. - Assist in the preparation and publication of research abstracts and manuscripts by working with biostatisticians, residents, and faculty to analyze completed data and write up research findings. - Consent patients for blood draws, urine or saliva collection in non-interventional, prospective research studies. May be required to prepare, process, and ship specimens and samples accurately under well-defined requirements. - May work closely with and assist the Clinical Research Coordinators on prospective trials. Non-Research Duties (50%) - Schedule meetings and interviews for faculty, update calendars, and reserve meeting locations. - Arrange travel in compliance with department, university, and sponsor policies. - Answer phone calls from patients and hospital support staff and forward to scheduling team and new patient coordinators. Communicate patients' concerns or questions to nurses and faculty. - Submit expense reimbursements for faculty. - Renew memberships and journal subscriptions for faculty. - Assist in billing patients and insurers by filling out relevant documents. - Retrieve and send faxes and routine correspondence regarding patient information and deliver scans to nurses. - Send emails to team members, hospital staff, and faculty. Respond promptly to email correspondence. Duties may vary based on faculty's research studies. Applicants are required to upload a cover letter and résumé to be considered for this opening. - - Other duties may also be assigned DESIRED QUALIFICATIONS: - Four year college degree in a related field. - Prior clinical or research experience, including undergraduate experience. - Experience with project management or coordination. - Experience working with healthcare professionals and clinical research participants. - Experience with University related research policies and procedures. - Experience working with Internal Review Boards - Organization, independence, and attention to detail. EDUCATION & EXPERIENCE (REQUIRED): Two-year college degree and one year of relevant experience or an equivalent combination of experience, education, and training. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): General knowledge of medical terminology. PHYSICAL REQUIREMENTS*: - Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. - Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. - Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. - - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. Additional PHYSICAL REQUIREMENTS: May need to travel to other Stanford locations to pick up biospecimen samples for research studies. WORKING CONDITIONS: - Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. - May require extended or unusual work hours based on research requirements and business needs. WORK STANDARDS: - Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. - Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. - Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu. The expected pay range for this position is $29.44 to $33.26 per hour. Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the university reasonably expects to pay for a position upon hire. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. Additional Information - Schedule: Full-time - Job Code: 1012 - Employee Status: Regular - Grade: E - Requisition ID: 108871 - Work Arrangement : Hybrid Eligible

• Support the operational execution of cell therapy clinical trials with a primary focus on vendor management, including central laboratory oversight. • Ensure vendors deliver high-quality, timely services aligned with study timelines, budgets, and regulatory requirements. • Oversee site feasibility, selection, contracting, start-up and close-out activities. • Conduct Monitoring Oversight Visits as needed. • Lead vendor oversight through governance structures, issue identification, escalation, and resolution. • Ensure central lab operational readiness, including lab manual review and site training coordination. • Partner closely with vendors to ensure timely, accurate data delivery. • Communicate vendor performance and escalate risks/issues to leadership as needed. • Contribute to development/review of study documents and support process improvements in vendor governance and central lab operations.