Senior Manager, Biostatistics

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:

$122,000.00 183,000.00

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

About You

You are genuinely passionate about our purpose

You bring precision and excellence to all that you do

You believe in our rooted-in-science approach to problem-solving

You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

You take pride in enabling the best work of others on the team

You can grapple with the unknown and be innovative

You have experience working in a fast-growing, dynamic company (or a strong desire to)

You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

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.

R13989

Remote/Remotely/Tele/Telecommute/From home