Vice President, Biometrics

Jobtailor; Deutschland; Remote; EUR 150.000 - 190.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a senior leader to oversee biostatistics and programming for oncology-focused clinical development and regulatory submissions. You will build and mentor a multidisciplinary team, develop innovative statistical methods, and ensure high-quality deliverables for FDA/EMA submissions.

The role requires extensive pharma/biotech experience, leadership, and a track record in oncology and NDA/BLA processes. Collaboration with senior stakeholders and CROs is essential.

Qualifikationen

• 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.
• Experience working in oncology and pancreatic cancer.

Aufgaben

• Oversee biostatistics and programming for clinical plans and trials.
• Build, lead, and manage the biostatistics team and mentoring junior staff.
• Provide strategic and technical leadership to a multidisciplinary team.
• Design, develop, and implement innovative statistical methods and data operations.
• Ensure quality of biostatistics deliverables.
• Provide statistical input to cross-functional teams and communicate complex concepts in lay language.
• Select CROs for outsourced biometrics and manage costs and timelines.
• Represent the company in FDA, EMA, and global regulator meetings.
• Apply oncology knowledge to trial designs, HEOR, and reimbursement requirements.
• Advise on publication strategy and scientific presentations.
• Engage with senior management and key opinion leaders.
• Partner on global development plans and endpoints, estimands, and confirmatory evidence plans.
• Establish governance for data integrity and submission readiness.
• Define departmental performance metrics and report on quality, delivery, budget, and risks to leadership.

Kenntnisse

Biostatistics Leadership

Clinical Trial Experience

Oncology Expertise

Regulatory Submission Knowledge

Statistical Programming

Ausbildung

MS/PhD in Statistics/Biostatistics

Tools

eCTD Submissions

NDA/BLA Submissions

Jobbeschreibung

• 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

Core Competencies

Demonstrates expertise in biostatistics and statistical programming, with a strong focus on clinical trial design and regulatory submissions in oncology. Proven leadership in managing multidisciplinary teams and fostering collaboration to achieve strategic clinical development goals.

Highest-signal resume keywords

• Biostatistics Leadership
• Clinical Trial Experience
• Oncology Expertise
• Regulatory Submission Knowledge
• Statistical Programming

Hard Skills

• Biostatistics
• Statistical Programming
• Clinical Trial Design
• Randomized Time To Event Data
• NDA/BLA Submissions
• ECTD Submissions
• Statistical Methods Development
• Data Integrity Management
• Performance Metrics Definition
• Cross-Functional Collaboration

Soft Skills

• Excellent Communication
• Interpersonal Skills
• Problem-Solving
• Leadership
• Mentoring

Certifications & Qualifications

• MS or PhD in Statistics
• Biostatistics or Related Field

Industry Keywords

• Pharma
• Biotech
• Oncology
• FDA
• EMA
• ICH Guidelines
• Pancreatic Cancer
• CRO Management
• Regulatory Health Authorities
• Translational Laboratory Data