Senior Manager, Biostatistics

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

Role Overview

Senior Manager, Biostatistics acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of concept, and/or as trial responsible statistician.

Responsibilities

• Act as lead and main point of contact related to Statistics for designated compound/indication
• Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies
• Engage with regulatory authorities on compound/indication level discussions
• Acts as a role model
• Ensures consistency of statistical methods and data handling across trials
• Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor
• Supports compound responsible programmer in developing an integrated database specification

CDT Member

• Responsible for giving statistical input to overall strategy and the synopsis development in the CDT
• Provide scientific advice to the CDT including design of trials, analyses and advanced statistical methodologies/techniques
• Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable
• Drive design and synopsis development together with relevant stakeholders
• Ensure transparent communication to relevant stakeholders from the CDT
• Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
• Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles

Trial Level

• Represent Genmab during meetings/congresses and courses and perform professional networking
• Engage with regulatory authorities on trial level discussions
• Arranges/attends lessons learned to share learnings
• Represents Genmab during Key Opinion Leaders meetings
• Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports
• Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable

CTT Member

• Participate and represent Biostatistics
• Review and provide input to protocol and amendment development
• Perform vendor oversight according to applicable SOPs
• Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings
• Review assay validation reports, as applicable
• Perform exploratory analysis, ad hoc analyses, and modelling of data
• Review and approve randomization and stratification plans
• Perform UAT of Randomization part of the IRT system as applicable
• Ensure procedures for blinding are in place as applicableSupport timely delivery of statistical deliverables
• Responsible for planning and conducting trial result meetings
• Review and approve the CSR
• Attend operational and steering committee meetings, as applicable
• Support regulatory submission/filing activities

Qualifications

• MS / PhD or equivalent in a statistical discipline
• 5+ years of experience in relevant area preferred or demonstrated capability
• Experience in statistical analysis, modelling and simulation and adaptive trial designs
• Experience in working with clinical trials
• Preferred experience with oncology clinical trials
• Proficient programming skills in statistical software’s, such as SAS
• Excellent oral and written communication skills
• Ability to work independently as well as in teams
• Confident, self‑reliant, and a quick learner
• Proactive and open‑minded
• Ability to prioritize and work in a fast‑paced and changing environment
• Result and goal‑oriented and committed to contributing to the overall success of Genmab

Compensation

US base salary range: $130,560.00 – $195,840.00. Additional compensation may include discretionary bonuses and long‑term incentives.

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well‑being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

About Genmab

Genmab is an international biotechnology company focused on improving the lives of patients through innovative antibody therapeutics. It has been developing next‑generation antibody platforms and data sciences for 25 years, with a pipeline that includes bispecific T‑cell engagers, antibody‑drug conjugates, immune checkpoint modulators and effector‑function‑enhanced antibodies. Genmab’s vision is to transform lives with Knock‑Your‑Sock‑Off (KYSO®) antibody medicines.

Genmab is headquartered in Copenhagen, Denmark and has a global presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and connect via LinkedIn and X.

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