Ph3Principal Statistician Oncology with Submission Experience /h3 pPosition Overview: Responsible for statistical oversight and support across all phases of oncology clinical trials, from protocol development through submission and reporting. /p h3Job Responsibilities /h3 ul liServe as a statistical department resource, mentor biostatisticians, and develop training plans. /li liDirect other biostatistics personnel on projects, ensuring timely, high‑quality work. /li liSupport all statistical tasks during the project lifecycle, from protocol to CSR. /li liPrepare or oversee the preparation of Statistical Analysis Plans (SAPs), including mock‑up displays for tables, listings, and figures. /li liLead biostatistician for protocol design, randomization schedule, and input to the clinical study report. /li liCreate or review programming specifications for datasets, tables, listings, and figures. /li liReview CRFs, database design, and other documentation to ensure protocol criteria are met. /li liImplement company objectives and develop alternative solutions to address business and operational challenges. /li liAct as the biostatistics representative on project teams and interface with other departmental representatives. /li liPrepare for internal meetings, contribute ideas, and demonstrate respect for others’ opinions. /li liVerify and conduct quality control of project deliverables, ensuring outputs meet SAP and specifications. /li liLead complex or multiple projects (e.g., submissions, integrated analyses), attend regulatory agency meetings or respond to questions to support statistical results of clinical trials. /li liManage scheduling and time constraints across multiple projects, set goals based on management priorities, and communicate difficulties with meeting timelines. /li liMonitor progress on study activities against milestones and ensure deliverables are met; identify out‑of‑scope tasks and report to management. /li liProvide statistical programming support as needed. /li liParticipate in DSMB and/or DMC activities, including charter development and serving as an independent or voting biostatistician. /li liFollow SOPs, work instructions, and regulatory guidelines (e.g., ICH). /li liMaintain organized, complete, and up‑to‑date project documentation and QC documents to ensure inspection readiness. /li liSupport business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. /li liPerform other work‑related duties as assigned. /li liMinimal travel may be required. /li /ul h3Qualification Requirements /h3 ul liGraduate degree in biostatistics or related discipline. /li liExtensive experience in clinical trials (or equivalent education and experience) demonstrating ability to lead multiple projects and programs. /li liProficiency in programming. /li liAbility to apply extensive knowledge of statistical design, analysis, regulatory guidelines, and programming techniques, and to communicate statistical concepts effectively. /li liExperience supporting all statistical tasks during the project lifecycle, from protocol to CSR. /li liExperience with regulatory submissions is preferred. /li liExcellent written and verbal communication skills. /li liAbility to read, write, speak, and understand English. /li /ul h3Summary /h3 pOncology experience is required. PhD/MS in statistics or related discipline with 6‑8 years of pharmaceutical experience. Broad knowledge and good understanding of advanced statistical concepts and techniques, with ability to conduct advanced analyses using SAS or R. /p pThe Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, and complies with the EU Equality Directive and related legislation. /p /p #J-18808-Ljbffr