Associate Director, Biostatistics – Clinical Development
Company: Genmab
Job ID: R13924
Category: Development Operations
Location: United States / Global (Remote Option)
Work Model: Remote / Hybrid
Career Level: Associate Director
Job Overview
Genmab is seeking an Associate Director, Biostatistics to provide statistical leadership and expertise across clinical development programs. This role serves as compound/indication lead and trial-responsible statistician for early- and late-stage programs, contributing to clinical trial design, strategy, and execution.
The ideal candidate will have strong experience in regulatory interactions, advanced statistical methodologies, adaptive trial designs, and oversight of complex clinical studies in oncology or related therapeutic areas.
Key Responsibilities
Compound/Indication Level
Act as the statistical lead and primary contact for designated compound(s) or indications.
Advise on new methodologies in biostatistics to improve innovation and trial efficiency.
Engage with regulatory authorities on statistical aspects of compound/indication development.
Ensure consistency of statistical methods and data handling across multiple trials.
Support integrated database specifications in collaboration with compound programmers.
Clinical Development Team (CDT) Participation
Provide statistical input to clinical development strategies, trial design, and synopsis development.
Offer scientific guidance on complex analyses, adaptive designs, and advanced statistical techniques.
Represent Genmab in regulatory meetings, KOL engagements, and partner discussions.
Ensure integrated analyses are planned and conducted to support development decisions, submissions, and marketing needs.
Trial Level
Represent Genmab during congresses, investigator meetings, and external collaborations.
Provide oversight and quality control of vendor-generated data and statistical outputs.
Review and approve randomization, stratification plans, statistical analysis plans (SAPs), and clinical study reports (CSRs).
Support trial-level regulatory submissions, including data packages for Data Monitoring Committees.
Ensure all trial-level biostatistical work aligns with Genmab SOPs, processes, and ICH-GCP standards.
CTT Member Responsibilities
Participate in cross-functional Clinical Trial Teams to review protocols, eCRF setups, edit checks, validation plans, and DSUR updates.
Perform exploratory and ad hoc analyses, modeling, and UAT of randomization systems as applicable.
Provide mentorship and oversight to junior biostatisticians and team members.
Required Qualifications
Master’s or PhD in Statistics or related discipline.
8+ years of experience in biostatistics for drug development, including regulatory interactions.
Expertise in statistical analysis, modeling, simulation, and adaptive trial designs.
Experience in biologics, targeted therapies, and companion diagnostics preferred.
Knowledge of FDA, EMA, ICH guidance, CDISC standards (SDTM, ADaM), and regulatory submissions (BLAs, INDs).
Proven track record of directing multiple complex projects or studies.
Strong analytical, problem-solving, and leadership skills.
Compensation (US-Based Roles)
Salary Range: USD 145,440 – 218,160 annually
Salary offers will consider experience, qualifications, and location. Eligible positions may include discretionary bonuses and long-term incentives.
Employee Benefits
401(k) plan with 100% match on first 6% contributions
Medical, dental, and vision insurance options
Paid vacation, sick leave, holidays, and 12 weeks discretionary parental leave
Wellness programs, tuition reimbursement, and Lifestyle Spending Account
Family support programs, financial wellness tools, and emotional well-being resources
Commuter benefits
About You
Passionate about Genmab’s mission and improving patient outcomes.
Brings precision and excellence in biostatistical analysis and trial oversight.
Thrives in fast-paced, dynamic environments while maintaining quality and compliance.
Collaborative, innovative, and committed to enabling the best work from your team.
Able to tackle unknowns, drive solutions, and mentor colleagues effectively.
About Genmab
Genmab is a global biotechnology leader focused on developing innovative antibody therapeutics to improve patient lives. With over 25 years of pioneering research, Genmab’s proprietary platforms include bispecific T-cell engagers, antibody-drug conjugates, and next-generation immune checkpoint modulators. Headquartered in Copenhagen, Denmark, Genmab operates across North America, Europe, and Asia-Pacific.
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