Vice President – Biometrics Consultant

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.