Senior Biostatistics Lead – Trials & Regulatory Strategy

Genmab; Princeton (NJ); On-site; USD 130,560 - 195,840; Full time

Benefits offered by this job

401(k) match

Health benefits

Parental leave

Commuter benefits

Tuition reimbursement

Lifestyle Spending Account

Job summary

Genmab is seeking a Senior Manager, Biostatistics to lead statistical activities in clinical development, guiding design, analyses, and regulatory discussions for select compounds up to proof of concept. You will coordinate with CDT and trial teams, ensuring consistent statistical methods and integrated analyses across studies.

The role requires a MS/PhD in statistics with 5+ years of biostatistics experience, strong SAS skills, and the ability to work both independently and in cross-functional

Qualifications

• MS or PhD (or equivalent) in statistics or a related field.
• 5+ years of experience in biostatistics or a closely related area preferred or demonstrated capability.
• Experience with statistical analysis, modelling, simulation, and adaptive trial designs.
• Experience working with clinical trials; oncology experience preferred.
• Excellent oral and written communication skills; ability to work independently and in teams.

Responsibilities

• Act as lead statistics contact for designated compound/indication.
• Advise on novel methodologies to improve efficiency in drug development.
• Engage with regulatory authorities on compound/indication level discussions.
• Ensure consistency of statistical methods and data handling across trials.
• Coordinate data transfers with partners, programmers, and data managers.
• Provide statistical input to trial design, analyses, and CP submissions.
• Review protocol, analysis plans, and trial results; support CSR preparation.

Skills

SAS

Communication

Independence

Proactiveness

Education

MS/PhD in statistics or related field

Tools

SAS

Job description

Genmab is seeking a Senior Manager, Biostatistics to lead statistical activities in clinical development, guiding design, analyses, and regulatory discussions for select compounds up to proof of concept. You will coordinate with CDT and trial teams, ensuring consistent statistical methods and integrated analyses across studies.

The role requires a MS/PhD in statistics with 5+ years of biostatistics experience, strong SAS skills, and the ability to work both independently and in cross-functional