Vice President, Biometrics; Consultant

Reporting to the Chief Medical Officer, this individual will serve as an integral team member with exposure to multiple facets of business operations. The Vice President, Biometrics (Consultant), will be accountable for ensuring that clinical evidence generation, data quality, statistical strategy, submission readiness, and biometrics operations are aligned with Company strategy, portfolio priorities, regulatory requirements, and capital-efficient execution. The Vice President, Biometrics (Consultant) will serve as the Company’s senior biometrics representative to global health authorities, partners, key opinion leaders, and other stakeholders.

Elicio Therapeutics (ELTX) is a growing organization based out of the Seaport area of Boston, Massachusetts with additional staff functioning in a virtual based environment from the Greater Boston area and throughout the United States.

The Vice President, Biometrics (Consultant), is responsible for all aspects of biostatistics and the statistical programming functions of the Company, provide strategic input to the clinical development plans, and ensuring the corporate objectives are met with high quality to enable regulatory filings. Major duties and responsibilities also include:

• Oversees the planning and execution of biostatistics, and statistical programing activities in support of clinical development plans, clinical trials, regulatory approval, and marketing goals aligned to corporate goals.
• Builds, leads and manages an effective biostatistics team including the development of standard department operating processes, and mentors junior staff.
• Provides strategic and technical leadership and supervision to a multidisciplinary team and responsible for the design, development, and/or implementation of innovative statistical methods, data and programming operations.
• Responsible for the overall quality of all biostatistics, statistical programming, and all relevant deliverables.
• Provides input to cross functional teams in making the best decisions and capable to articulate complex statistical concepts into lay language; makes timely and calculated decisions to change the course of action when necessary.
• Lead the selection of CROs (external vendors) for outsourced biometrics activities; accountable for costs, timeliness, and quality of the deliverables.
• Utilize the experience with the regulatory submission process and represents the company at meetings with global regulatory health authorities, including extensive engagement in the discussions with and present company’s positions at meetings with FDA, EMA and/or other regulatory agencies.
• Apply the comprehensive understanding of the oncology disease landscape of interests which includes but not limited to trial designs, competitions, operational understanding of HEOR and reimbursement requirements.
• Advise and support publication strategy, scientific presentations, and the assessment of translational laboratory data.
• May engage in strategic discussions with senior management, advisory boards, and key opinion leaders on topics relevant to the product candidates.
• Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team.
• Partner with Clinical Development and Regulatory Affairs to shape integrated global development plans, including target product profiles, indication strategy, endpoint selection, control-arm strategy, estimands, statistical assumptions, and confirmatory evidence plans.
• Provide independent, data-driven recommendations on portfolio prioritization, clinical program advancement, indication expansion, go/no-go decisions, protocol…