Associate Director, Programming Statistical Computing Environment (SCE)

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!

Associate Director – Statistical Computing Environment

The Associate Director - Statistical Computing Environment (SCE) serves as the Business System Owner for Genmab’s validated Statistical Computing Platform. This role is accountable for ensuring the platform remains fit for intended use and compliant with global GxP requirements while leading business adoption, roadmap evolution, and operational excellence. Operating within the Programming Process, Standards, and Technology organization, the Associate Director partners with IT, QA, vendors, and the cross-functional user community to maintain the validated state of the SaaS-based computing environment and drive continuous improvement of the platform.

Responsibilities

• Serve as Business System Owner for the Statistical Computing Environment, accountable for maintaining the validated state of the GxP platform in partnership with IT, QA, and vendors.

• Lead validation lifecycle activities from the business perspective, including change impact assessment, user acceptance testing (UAT), regression testing, and approval of vendor validation documentation.

• Manage and assess vendor-driven system releases and changes, ensuring appropriate risk evaluation, documentation updates, communication, and testing prior to deployment.

• Conduct and document periodic system review to confirm continued fitness for intended use, access governance, compliance posture, and vendor performance.

• Participate in deviation management and CAPA activities related to system functionality or compliance.

• Ensure business-level compliance with global regulations and maintain inspection readiness of documentation, processes, and system controls.

• Define and prioritize platform roadmap in alignment with clinical and statistical programming strategy.

• Lead operational oversight and end-user support, ensuring high service levels and effective issue resolution.

• Lead end-user training and engagement initiatives to communicate system updates and drive adoption of new capabilities.

• Author and maintain controlled process documentation governing system usage, environment management, and user access.

• Partner with IT and QA on supplier qualification, vendor oversight, and review of audit/SOC documentation for the SaaS platform.

• Represent Statistical Programming in cross-functional governance forums to align system capabilities with enterprise needs.

• Support internal audits and regulatory inspections as the business representative for the Statistical Computing Environment.

• Collaborate with IT, Digital Development, and other business product owners to enable platform integrations and interoperability across our end-to-end workflow.

Qualifications

• Bachelor’s or Master’s degree in statistics, biostatistics, computer science, or related field.

• 10+ years of experience in pharmaceutical/biotech environments supporting validated GxP computerized systems.

• Demonstrated experience serving as Business or Application System Owner for a GxP platform, preferably in a SaaS or cloud-hosted model.

• Strong working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GxP SDLC, change control, and data integrity principles (ALCOA+).

• Experience reviewing vendor validation documentation and leading UAT/regression testing in a regulated environment.

• Experience supporting inspection readiness, internal audits, and regulatory inspections.

• Practical knowledge of statistical programming environments (e.g., SAS, R) and associated file, package, and workflow management.

• Experience operating within a vendor-based validation model and assessing business impact of SaaS platform releases.

• Strong analytical and organizational skills with demonstrated accountability and ability to manage competing priorities.

• Knowledge of open-source package governance and reproducible environment strategies, a plus.

• Active participation in relevant industry organizations (e.g., PHUSE, CDISC), a plus.

For US based candidates, the proposed salary band for this position is as follows:

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.