Senior Manager, Biostatistics

Genmab

5+ years

USD 122,000 – 183,000

Remote

10 Jan. 2, 2026

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Manager, Biostatistics – Oncology & Biologics

Company: Genmab
Job ID: R13989
Category: Development Operations
Locations: Multiple (USA)
Career Level: Mid-Senior

About the Role

Genmab is seeking a Senior Manager, Biostatistics to provide statistical leadership and oversight across clinical development programs, primarily up to proof-of-concept. The role involves supporting compound/indication-level planning, trial-level statistical analysis, and cross-functional collaboration, ensuring regulatory compliance and data integrity. This position also acts as a mentor and scientific advisor, providing guidance on innovative biostatistical methodologies to improve efficiency and quality in clinical trials.

Key Responsibilities

Compound/Indication Level

Serve as statistical lead and main point of contact for designated compounds/indications.
Ensure consistency of statistical methods and data handling across trials.
Collaborate with regulatory authorities and engage in compound-level discussions.
Provide guidance on integrated database specifications and analysis strategies.
Stay current with advancements in biostatistics and recommend innovative methodologies.

Clinical Development Team (CDT) Engagement

Contribute statistical input to overall trial strategy and protocol/synopsis development.
Provide scientific advice on trial design, advanced analyses, and adaptive methodologies.
Represent Genmab in regulatory meetings, Key Opinion Leader engagements, and partner meetings.
Facilitate integrated analyses to support development decisions, submissions, and marketing needs.
Support scientific communication, including presentations, posters, and publications.

Trial Level Responsibilities

Provide biostatistical oversight for protocol development, statistical analysis plans (SAPs), tables, figures, and listings.
Conduct exploratory analyses, ad hoc analyses, and modeling of clinical trial data.
Review assay validation reports, randomization and stratification plans, and IRT system testing.
Ensure blinding procedures are properly implemented.
Support regulatory submissions and Clinical Study Report (CSR) preparation.
Participate in vendor oversight, trial operational meetings, and lessons learned sessions.

Cross-Functional & Leadership Activities

Mentor junior biostatisticians and act as a role model within the department.
Promote transparent communication and knowledge sharing across teams.
Engage in scientific networking at conferences, congresses, and workshops.
Drive continuous improvement of statistical methods, processes, and tools.

Requirements

MS or PhD in Statistics, Biostatistics, or a related discipline.
5+ years of experience in biostatistics within clinical development (oncology experience preferred).
Strong expertise in statistical analysis, modeling, simulation, and adaptive trial designs.
Experience with clinical trials and regulatory submission processes.
Proficient in statistical programming tools, such as SAS; knowledge of R is a plus.
Excellent written and oral communication skills.
Ability to work independently and collaboratively in a fast-paced, evolving environment.
Proactive, result-oriented, and committed to supporting the success of Genmab.

Compensation (US-Based Roles)

Salary Range: USD 122,000 – 183,000 annually
Salary offers depend on experience, qualifications, and location. Certain roles may include discretionary bonuses or long-term incentives.

Employee Benefits

401(k) plan with 100% match on first 6% contributions
Comprehensive medical, dental, and vision insurance
Paid vacation, sick leave, holidays, and 12 weeks discretionary parental leave
Wellness programs, tuition reimbursement, Lifestyle Spending Account
Family support programs, financial wellness tools, and emotional well-being resources
Commuter benefits

About You

Passionate about Genmab’s mission to improve patient outcomes.
Detail-oriented, analytical, and precise in statistical planning and execution.
Strong collaborator able to lead cross-functional teams.
Innovative and proactive in applying advanced statistical methodologies.
Committed to compliance, quality, and scientific excellence.

About Genmab

Genmab is a global biotechnology company dedicated to developing innovative antibody therapeutics that transform patient care. With over 25 years of experience, Genmab has pioneered next-generation antibody platforms, including bispecific T-cell engagers, antibody-drug conjugates, and immune checkpoint modulators. Headquartered in Copenhagen, Denmark, Genmab has a presence across North America, Europe, and Asia-Pacific.

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Senior Manager, Biostatistics

Job Description

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