Biostatistics Lead: Trial Design & Regulatory Strategy

Genmab; København; On-site; DKK 853,891 - 1,280,836; Full time

Benefits offered by this job

401(k) Plan match

Health benefits

Voluntary insurance

Paid time off

Parental leave

Wellness programs

Commuter benefits

Tuition reimbursement

Lifestyle Spending Account

Job summary

Genmab is seeking a Senior Manager, Biostatistics to lead statistics for designated compounds and indications, guiding trial design, analyses, and regulatory discussions. You will coordinate with trial teams, CDT members, and vendors to ensure robust statistical methodology and integrated analyses supporting decisions and regulatory submissions.

The role requires deep biostatistics expertise, experience with clinical trials (oncology preferred), and strong communication.

Qualifications

• MS/PhD in statistics or equivalent.
• 5+ years of experience in biostatistics or related field preferred or demonstrated capability.
• Experience in statistical analysis, modelling and simulation and adaptive trial designs.
• Experience in working with clinical trials, preferably oncology.
• Proficient programming skills in SAS.

Responsibilities

• Act as lead and main point of contact related to Statistics for designated compound/indication.
• Follow scientific progress in biostatistics and advise on new methodologies.
• Engage with regulatory authorities on compound/indication level discussions.
• Ensure consistency of statistical methods and data handling across trials.
• Coordinate data transfers with partners and the programmer/data manager.
• Provide statistical input to the CDT and support integrated analyses for development decisions.

Skills

SAS

Statistical analysis

Oral & written communication

Independent worker

Teamwork

Education

MS/PhD in statistics

Tools

SAS

Job description

Genmab is seeking a Senior Manager, Biostatistics to lead statistics for designated compounds and indications, guiding trial design, analyses, and regulatory discussions. You will coordinate with trial teams, CDT members, and vendors to ensure robust statistical methodology and integrated analyses supporting decisions and regulatory submissions.

The role requires deep biostatistics expertise, experience with clinical trials (oncology preferred), and strong communication.