Lead biostatistician Vacatures

Over de vacature

Overview

In this role you lead statistical strategy and execution for designated compounds/indications in early and late-stage programs. You engage with regulators, ensure consistent statistical methods across trials, and drive integrated data analyses to support development decisions. You contribute to trial design, analysis plans, and regulatory meetings, acting as a key scientific advisor within the CDT and trial teams. This position offers the chance to shape how Genmab advances pioneering antibody medicines that aim to transform patient outcomes. You will work in a collaborative, data-driven environment that values scientific rigor and impactful cancer therapy development.

Arbeidsvoorwaarden / Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health benefits: medical, dental, vision
• Paid time off: vacation, sick leave, holidays; discretionary parental leave
• Voluntary plans: critical illness, accident, hospital indemnity
• Backup care and family support programs
• Tuition reimbursement and Lifestyle Spending Account

Verantwoordelijkheden

• Act as lead and main Statistics contact for designated compound/indication
• Stay current with biostatistics developments and advise on innovative methodologies
• Engage with regulatory authorities on compound/indication level discussions
• Ensure consistency of statistical methods and data handling across trials
• Share compound/indication related work among biostatisticians and with vendors
• Support integrated database specification development with the programming team
• Provide statistical input to overall CDT strategy and synopsis development
• Advise on trial design, analyses, and advanced statistical techniques within CDT
• Represent CDT/company at regulatory meetings, KOLs, and partner meetings
• Drive design and synopsis development with stakeholders
• Ensure integrated databases availability and plan integrated analyses for development decisions
• Support development and communication related to presentations, posters, and articles
• Attend and present at meetings, congresses, and courses for professional networking
• Ensure biostatistician reviews of protocols, SAPs, results meetings, and trial reports
• Coordinate data transfers with partners alongside programmers and data managers
• Apply state-of-the-art statistical methods with solid scientific foundation
• Maintain proper documentation and oversee QC of vendor data and analyses
• Ensure trial work complies with Genmab SOPs, processes, and ICH-GCP
• Participate in regulatory data package discussions with Data Monitoring Committees
• Contribute to data integrity, transparency, and timely delivery of statistical deliverables

Belangrijkste vereisten

• Master's or PhD in statistics or a related field

• 8+ years of relevant experience preferred

• Experience in statistical analysis, modeling, simulation, and adaptive trial designs

• Biologics, targeted therapies, and companion diagnostics exposure preferred

• Experience with FDA, EMA, and ICH guidelines for statistics in drug development

• Experience with regulatory submissions (BLAs) and interactions with health authorities

• Proficiency with SDTM, ADaM, eSUB, and CDISC for regulatory submissions

• Track record of managing multiple complex projects in a technical role

• Proven ability to work with cross-functional teams and vendors

• Strong communication and leadership skills

• collaboration

• communication

• leadership

• statistical methods for drug development

• adaptive trial designs

• regulatory statistics

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

Over de vacature

Overview

As Senior Manager, Biostatistics, you will lead statistical support for designated compounds and indications, guiding trial design, analyses, and regulatory interactions. You'll collaborate across CDT, CTT, and vendor teams to ensure consistent methods and transparent data handling. You'll contribute to strategy, integrated analyses, and scientific communication, shaping development decisions through advanced statistics. This role sits at the heart of Genmab's mission to deliver impactful antibody medicines and drive oncology innovation.

Arbeidsvoorwaarden / Benefits

• 401(k) with 100% match up to 6%
• Comprehensive health benefits (medical, dental, vision)
• Voluntary insurance plans (critical illness, accident)
• Paid vacation, sick leave, holidays, parental leave
• Backup care and family support resources
• Tuition reimbursement and lifestyle spending account

Verantwoordelijkheden

• Act as lead statistician and main statistics contact for designated compound/indication
• Advise on innovative biostatistical methodologies to improve efficiency
• Engage with regulatory authorities on compound/indication level discussions
• Ensure consistency of statistical methods and data handling across trials
• Facilitate information sharing among biostatisticians and vendors
• Support integrated database specifications and planning for integrated analyses
• Provide statistical input to CDT strategy and synopsis development
• Represent the CDT/company at regulatory, KOL, and partner meetings
• Oversee protocol design and amendments, analysis plans, and results communication
• Coordinate data transfers with partners, programmer, and data manager
• Review eCRF setup, validation plans, and trial randomization/DSUR
• Support timely delivery of statistical deliverables and trial result meetings
• Review CSR and support regulatory submission activities

Belangrijkste vereisten

• MS / PhD or equivalent in statistics

• 5+ years in relevant area (preferred)

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

• Experience with clinical trials, oncology preferred

• Proficient in SAS or equivalent statistics software

• Excellent oral and written communication

• Ability to work independently and in teams

• Proactive, quick learner, and able to thrive in fast-paced environments

• Goal-oriented and able to contribute to Genmab's success

• oral and written communication

• independence and teamwork

• proactivity

• statistical analysis

• modelling and simulation

• adaptive trial designs