Job Description

Job DetailExperience Level Sr DirectorDegree Type Doctor of Philosophy (PhD)Employment ContractWorking Type RemoteJob Reference 0000021201Salary Type AnnuallyIndustry Pharmaceuticals;BiotechnologySelling Points Lead biometrics operations for innovative oncology-focused clinical trials. Collaborate with global health authorities and stakeholders to ensure submission readiness. Drive strategic statistical initiatives in a dynamic environment.Job DescriptionVice President – Biometrics Consultant OverviewThe 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 & DutiesOversee 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 RequirementsPhD 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.

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