Director biostatistics clinical development Vacatures

Over de vacature

Overview

In this Director role you serve as the statistical expert for clinical development, leading statistics for designated compounds or indications across early and late-stage programs. You will shape development strategies, engage with regulators, and ensure rigorous statistical methods across trials. You collaborate with cross-functional teams to enable integrated analyses and timely submissions, driving scientific rigor and strategic decisions. This position offers impact in advancing Genmab's mission to deliver innovative antibody medicines for cancer and serious diseases. You will lead, influence stakeholders, and contribute to cutting-edge biostatistics in a high impact environment.

Arbeidsvoorwaarden / Benefits

• 401(k) match on contributions
• health benefits (medical, dental, vision)
• voluntary plans (critical illness, accident, hospital indemnity)
• paid time off and parental leave
• backup care and family support programs
• tuition reimbursement

Verantwoordelijkheden

• Act as lead statistician and primary contact for designated compound/indication
• Stay current with biostatistics advances and advise on new methods
• Engage with regulatory authorities on compound/indication level discussions
• Promote consistency of statistical methods and data handling across trials
• Share compound/indication related work with biostatisticians and vendors
• Support integrated database specification development with the responsible programmer
• Provide statistical input to overall CDT strategy and synopsis development
• Advise on trial design, analyses, and advanced methods for the CDT
• Represent the CDT/company at regulatory, KOL, and partner meetings
• Drive design and synopsis development with stakeholders
• Ensure integrated databases and analyses support development decisions and submissions
• Contribute to communication strategies and scientific presentations

Belangrijkste vereisten

• Master's or PhD in statistics or related field

• 12+ years of relevant experience (preferred)

• Experience in statistical analysis, modelling, and adaptive trial designs

• Experience in drug development for biologics, targeted therapies, and companion diagnostics (preferred)

• Experience with FDA, EMA, ICH guidelines and regulatory submissions (BLAs)

• Experience with SDTM, ADaM, eSUB, and CDISC requirements

• Proven leadership and mentoring of teams

• Vendor oversight and collaboration across CROs

• Ability to manage multiple complex projects and deliver statistical deliverables

• Experience with regulatory discussions/negotiations in filing strategies

• collaboration and cross-functional communication

• leadership and mentoring

• stakeholder management

• biostatistics leadership in clinical development

• statistical modelling and adaptive trial designs

• regulatory submissions and data packages