Vice President, Biometrics

Job not on LinkedIn

🔥 8 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $225 - $325 / hour

⏳ Contract/Temporary

🔴 Lead

👔 Vice President

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Elicio

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

⚡ Energy

Energy

Elicio is an international renewable energy producer that develops, builds and operates high-tech onshore and offshore wind farms. Headquartered in Belgium with operations in several European countries, the company focuses on designing, constructing and maintaining wind parks and partnering with major energy suppliers to deliver clean, large-scale wind power. Elicio emphasizes innovation, sustainability and circularity in wind-turbine lifecycle management.

📋 Description

• Oversee biostatistics and statistical programming activities supporting clinical development plans, clinical trials, regulatory approval, and marketing goals • Build, lead, and manage the biostatistics team, including developing standard operating processes and mentoring junior staff • Provide strategic and technical leadership to a multidisciplinary team • Design, develop, and/or implement innovative statistical methods, data, and programming operations • Ensure the quality of biostatistics, statistical programming, and relevant deliverables • Provide statistical input to cross-functional teams and communicate complex statistical concepts in lay language • Select CROs for outsourced biometrics activities and manage costs, timelines, and deliverable quality • Represent the company in meetings with FDA, EMA, and other global regulatory health authorities • Apply oncology disease landscape knowledge to trial designs, competition, HEOR, and reimbursement requirements • Advise on publication strategy, scientific presentations, and translational laboratory data • Engage with senior management, advisory boards, and key opinion leaders • Promote collaboration, inclusion, execution excellence, communication, and cross-functional problem-solving • Partner with Clinical Development and Regulatory Affairs on global development plans, target product profiles, indication strategy, endpoints, control-arm strategy, estimands, statistical assumptions, and confirmatory evidence plans • Provide data-driven recommendations on portfolio prioritization, program advancement, indication expansion, go/no-go decisions, protocol amendments, and risk mitigation • Establish biometrics governance forums and decision-making processes for data integrity, statistical validity, database readiness, endpoint reliability, and submission readiness • Define departmental performance metrics and report quality, delivery, budget, resource utilization, regulatory readiness, and program risks to executive leadership

🎯 Requirements

• MS or PhD in statistics, biostatistics or related field • Minimum of 15 years of experience in Pharma and/or Biotech • Extensive clinical trial experience, including randomized time to event data • Minimum of 10 years in leadership roles • Excellent communication, written, and interpersonal skills • Demonstrated strong leadership skills • Ability to solve complex issues and collaborate effectively with cross-functional teams • Ability to work in a fast-paced environment and manage competing priorities • Recent experience in oncology • Pancreatic cancer experience • Experience working in small pharmaceutical/biotech companies • Familiarity with ICH guidelines, FDA, EMA, and global regulator requirements • NDA/BLA experience, including eCTD submissions in oncology • Ability to work as a 1099 Independent Contractor

🏖️ Benefits

• Remote work option • Employees near Boston may come onsite, though it is not a regular requirement • Travel to company headquarters a few times per year if necessary