Vice President – Biometrics Consultant Overview • The Vice President – Biometrics Consultant will oversee biometrics operations, ensuring alignment with clinical evidence generation, regulatory requirements, and strategic priorities. • This role involves leading statistical strategy, submission readiness, and data quality initiatives to support oncology-focused clinical trials. • Collaborate with cross-functional teams to shape integrated global development plans and provide data-driven recommendations on portfolio prioritization. • Represent the organization in discussions with global health authorities, partners, and stakeholders, ensuring biometrics excellence. • Promote a culture of collaboration, execution excellence, and effective communication within the biometrics team. • Engage in strategic discussions with senior management and advisory boards on product candidate developments. • Contribute to publication strategies and scientific presentations, supporting translational laboratory data assessments. • Join a clinical-stage biotechnology company advancing innovative immunotherapy platforms targeting oncology, particularly solid tumors. Vice President – Biometrics Consultant Key Responsibilities & Duties • Oversee biostatistics and statistical programming activities to support clinical trials and regulatory submissions. • Lead the development of departmental processes and mentor junior staff within the biometrics team. • Provide strategic and technical leadership for innovative statistical methods and programming operations. • Ensure the quality of biometrics deliverables and articulate complex statistical concepts effectively. • Select and manage external vendors for outsourced biometrics activities, ensuring cost-effective and timely deliverables. • Engage with global regulatory health authorities to represent the organization’s positions and strategies. • Advise on trial designs, endpoint selection, and confirmatory evidence plans for oncology-focused studies. • Define departmental performance metrics and report on quality, delivery, and key program risks. Vice President – Biometrics Consultant Job Requirements • PhD in statistics, biostatistics, or related field with 15+ years of experience in Pharma/Biotech. • 10+ years of leadership experience in clinical trials, including randomized time-to-event data. • Expertise in oncology, particularly pancreatic cancer, and familiarity with ICH guidelines and global regulatory requirements. • Strong communication, leadership, and problem-solving skills in fast-paced environments. • Experience with NDA/BLA submissions, including eCTD submissions in oncology. • Proven ability to collaborate with cross-functional teams and manage competing priorities effectively. • Knowledge of HEOR and reimbursement requirements in oncology clinical trials. • Remote work flexibility with occasional travel as needed.