Senior Manager, Biostatistics

About Genmab

Genmab is an international biotechnology company dedicated to creating antibody products and groundbreaking antibody medicines that change lives and the future of cancer treatment and serious diseases. We foster a global workplace where unique contributions are valued and drive innovative solutions. Our people are compassionate, candid, and purposeful, with an innovative, science-rooted business. We pride ourselves on being authentic and determined to be our best in fulfilling our purpose.

The Role

The Senior Manager, Biostatistics will act as a biostatistician supporting the clinical development of compounds. This role is primarily focused on supporting development up until proof of concept, and/or acting as the trial responsible statistician.

Responsibilities

Compound/Indication Level

• Act as the lead and main point of contact for Statistics for designated compound/indication.
• Follow scientific and technical progress within biostatistics in drug development and advise on new methodologies for innovation and efficiency.
• Engage with regulatory authorities on compound/indication level discussions.
• Act as a role model for the team.
• Ensure consistency of statistical methods and data handling across trials.
• Ensure all compound/indication related work and information is shared among involved biostatisticians and with vendors.
• Support the compound responsible programmer in developing integrated database specifications.

CDT Member

• Provide statistical input to overall strategy and synopsis development within the Clinical Development Team (CDT).
• Offer scientific advice to the CDT on trial design, analyses, and advanced statistical methodologies.
• Represent the CDT/company at regulatory meetings, Key Opinion Leader meetings, and network/partner meetings.
• Drive design and synopsis development with relevant stakeholders.
• Ensure transparent communication to relevant CDT stakeholders.
• Ensure availability of integrated databases and plan/conduct integrated analyses for development decisions, submissions, and marketing needs.
• Support development and communication strategies, including scientific input for presentations, posters, and articles.

Trial Level

• Represent Genmab at meetings, congresses, and courses, engaging in professional networking.
• Engage with regulatory authorities on trial-level discussions.
• Organize and attend lessons learned sessions to share insights.
• Represent Genmab during Key Opinion Leader meetings.
• Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings, presentations, and clinical trial reports.
• Coordinate data transfers with business partners in collaboration with programmers and data managers.

CTT Member

• Participate and represent Biostatistics within the Clinical Trial Team (CTT).
• Review and provide input on protocols and amendments.
• Perform vendor oversight according to applicable Standard Operating Procedures (SOPs).
• Provide input on eCRF setup, edit checks, validation plans, protocol deviations, DSUR, IB updates, tables, figures, and listings.
• Review assay validation reports.
• Perform exploratory analysis, ad hoc analyses, and data modeling.
• Review and approve randomization and stratification plans.
• Perform User Acceptance Testing (UAT) of the randomization component of the Interactive Response Technology (IRT) system.
• Ensure blinding procedures are in place.
• Support timely delivery of statistical deliverables.
• Plan and conduct trial result meetings.
• Review and approve the Clinical Study Report (CSR).
• Attend operational and steering committee meetings.
• Support regulatory submission/filing activities.

Requirements

• MS / PhD or equivalent in a statistical discipline.
• 5+ years of experience in a relevant area preferred, or demonstrated capability.
• Experience in statistical analysis, modeling, simulation, and adaptive trial designs.
• Experience working with clinical trials.
• Preferred experience with oncology clinical trials.
• Proficient programming skills in statistical software such as SAS.
• Excellent oral and written communication skills.
• Ability to work independently and in teams.
• Confident, self-reliant, and a quick learner.
• Proactive and open-minded.
• Ability to prioritize and work in a fast-paced, changing environment.
• Result and goal-oriented and committed to contributing to Genmab's success.

Salary and Benefits (US Based Candidates)

The proposed salary band for this position is $122,000.00 - $183,000.00. The actual salary offer will consider skills, qualifications, experience, and location. Certain positions may be eligible for additional compensation such as discretionary bonuses and long-term incentives.

When you join Genmab, you become part of a culture that supports your physical, financial, social, and emotional wellness. Benefits include a 401(k) plan with a 100% match, health benefits (medical, dental, vision), voluntary plans, generous paid time off, and support resources for family and emotional well-being.

About You

• Genuinely passionate about Genmab's purpose.
• Bring precision and excellence to your work.
• Believe in a science-rooted approach to problem-solving.
• A generous collaborator comfortable working in diverse teams.
• Take pride in enabling the best work of others.
• Can grapple with the unknown and be innovative.
• Experience in a fast-growing, dynamic company or a strong desire to gain it.
• Work hard and enjoy the process.

Locations

Genmab utilizes an agile working environment to enhance employee work-life balance. Our offices are designed as open, community-based spaces that foster connection. We thrive on connecting with each other to innovate, whether in our office spaces or working remotely.

Key skills/competency

• Biostatistics
• Clinical Trials
• SAS Programming
• Statistical Analysis
• Modeling and Simulation
• Adaptive Trial Designs
• Oncology
• Regulatory Affairs
• Data Management
• Team Collaboration