Associate Director, Biostatistics | Remote / Home-Based (Global)
Job ID: R13924
Category: Development Operations / Biostatistics
Job Type: Full-Time
Locations: Flexible / Remote – Global; office options in North America and Europe
About Genmab
Genmab is a global biotechnology company committed to improving patient lives through innovative and differentiated antibody therapeutics. With 25 years of pioneering experience, Genmab develops next-generation antibody technologies, including bispecific T-cell engagers, antibody-drug conjugates, and immune checkpoint modulators.
Headquartered in Copenhagen, Denmark, Genmab operates internationally across North America, Europe, and Asia-Pacific, with a vision to transform cancer treatment and serious diseases through its proprietary Knock-Your-Socks-Off (KYSO®) antibody medicines.
Learn more at www.genmab.com and follow Genmab on LinkedIn and X.
Role Overview
The Associate Director, Biostatistics will act as a statistical expert providing leadership across early- and late-stage clinical development programs. This role involves serving as a compound/indication lead or trial responsible statistician, contributing to clinical development strategies, and ensuring the highest standards in statistical design, analysis, and reporting.
This is a global, remote-friendly role, engaging with cross-functional teams, regulatory authorities, and external partners.
Key Responsibilities
Compound / Indication Leadership
Serve as lead statistical contact for designated compounds/indications.
Advise on biostatistical methodologies and new approaches to improve clinical development efficiency.
Engage with regulatory authorities on compound/indication level discussions.
Ensure consistency of statistical methods and data handling across trials.
Collaborate with programmers and vendors to develop integrated database specifications.
Clinical Development Team (CDT) Contributions
Provide statistical input to overall program strategy and synopsis development.
Offer advanced statistical advice for trial design, analysis, and innovative methodologies.
Represent Genmab at regulatory, Key Opinion Leader, and partner meetings.
Plan and conduct integrated analyses to support development decisions and submissions.
Contribute scientific input to presentations, posters, and publications.
Trial-Level Responsibilities
Oversee statistical review of protocols, statistical analysis plans, results meetings, and clinical study reports (CSRs).
Ensure adherence to ICH-GCP, SOPs, and regulatory standards.
Perform exploratory analyses, modeling, and support ad hoc analyses as needed.
Participate in trial and investigator meetings, including lessons learned sessions.
Coordinate data transfers and perform vendor oversight for trial-related statistical work.
Cross-Functional Collaboration
Partner with Genmab Global Drug Safety to define, review, and approve data packages for Data Monitoring Committees.
Support regulatory submissions, filings, and interactions with health authorities.
Facilitate transparent communication of statistical insights across teams.
Required Qualifications
Master’s or PhD in Statistics, Biostatistics, or related discipline
Minimum 8 years of relevant experience, with demonstrated capability in biostatistics for drug development
Strong expertise in statistical analysis, modeling, simulation, and adaptive trial design
Experience in biologics, targeted therapies, and companion diagnostics preferred
Knowledge of regulatory standards and guidelines (FDA, EMA, ICH) for biostatistics and clinical trials
Familiarity with SDTM, ADaM, eSUB, and CDISC standards for regulatory submissions
Proven ability to lead multiple complex projects and cross-functional teams
Excellent written and verbal communication skills, strategic thinking, and collaborative mindset
Preferred Qualifications
Previous experience engaging with regulatory authorities on filings and statistical strategy
Track record of contributions to global submissions, including BLAs
Experience directing trial-level biostatistics for both early- and late-stage clinical programs
Expertise in integrated analyses and planning for development decision-making
Compensation and Benefits (US-Based Candidates)
Base Salary Range: USD 145,440 – 218,160 per year
Eligibility for discretionary bonuses and long-term incentives
Comprehensive health, dental, and vision coverage
401(k) retirement plan with company match
Paid vacation, sick leave, holidays, and parental leave
Support for wellness, financial planning, and lifestyle needs
About You
Passionate about innovative, science-driven solutions for patients
Detail-oriented with precision and excellence in all deliverables
Collaborative, adaptable, and able to thrive in dynamic, global environments
Able to balance high standards with creativity and problem-solving
Experienced in fast-paced organizations or eager to grow in one
Equal Opportunity Statement
Genmab is committed to a diverse and inclusive workplace. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability status, veteran status, or any legally protected characteristic.
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