About the role
At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
The Role
The 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
Compound/Indication Level
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 analyses requiring 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 etc.
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 applicable
Support 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
Requirements
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
For US based candidates, the proposed salary band for this position is as follows:
$130,560.00 - $195,840.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
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
Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.