Vice President, Biometrics

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee biostatistics and statistical programming efforts that support clinical development strategies, clinical trials, regulatory approvals, and marketing objectives.

• Build, lead, and manage a biostatistics team, which includes creating standard operating procedures and mentoring junior personnel.

• Provide strategic and technical leadership to a multidisciplinary team.

• Design, develop, and/or implement innovative statistical methodologies, data management, and programming operations.

• Ensure the quality of biostatistical work, statistical programming, and associated deliverables.

• Offer statistical insights to cross-functional teams and convey complex statistical ideas in accessible language.

• Select Contract Research Organizations (CROs) for outsourced biometrics activities while managing costs, timelines, and quality of deliverables.

• Represent the company in discussions with the FDA, EMA, and other global regulatory health authorities.

• Utilize knowledge of the oncology disease landscape to inform trial designs, competitive analysis, health economics and outcomes research (HEOR), and reimbursement considerations.

• Provide guidance on publication strategies, scientific presentations, and translational laboratory data.

• Engage with senior management, advisory boards, and key opinion leaders.

• Foster collaboration, inclusivity, execution excellence, communication, and cross-functional problem-solving.

• Collaborate with Clinical Development and Regulatory Affairs on global development strategies, target product profiles, indication strategies, endpoints, control-arm strategies, estimands, statistical assumptions, and confirmatory evidence plans.

• Deliver data-driven recommendations regarding portfolio prioritization, program advancement, indication expansion, go/no-go decisions, protocol amendments, and risk mitigation.

• Establish biometrics governance forums and decision-making processes focused on data integrity, statistical validity, database readiness, endpoint reliability, and submission readiness.

• Define departmental performance metrics and report on quality, delivery, budget, resource utilization, regulatory preparedness, and program risks to executive leadership.

⛳️ Requirements

• MS or PhD in statistics, biostatistics, or a related field.

• A minimum of 15 years of experience in the pharmaceutical and/or biotech sector.

• Extensive experience in clinical trials, particularly with randomized time-to-event data.

• At least 10 years of experience in leadership positions.

• Exceptional communication, writing, and interpersonal abilities.

• Proven strong leadership capabilities.

• Aptitude for resolving complex issues and collaborating effectively with cross-functional teams.

• Capacity to thrive in a fast-paced environment and manage competing priorities.

• Recent experience in oncology.

• Experience with pancreatic cancer.

• Background in small pharmaceutical or biotechnology companies.

• Knowledge of ICH guidelines, as well as FDA, EMA, and global regulatory requirements.

• Experience with NDA/BLA submissions, including eCTD submissions in oncology.

• Ability to work as a 1099 Independent Contractor.

🏝️ Benefits

• Option for remote work.

• Employees located near Boston may be able to work onsite, though this is not a regular requirement.

• Occasional travel to the company headquarters a few times per year, if necessary.