Associate Director, Programming Statistical Computing Environment

Genmab • Princeton, FL

2d

About The Position

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 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.

Requirements

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

Nice To Haves

• Knowledge of open-source package governance and reproducible environment strategies, a plus.
• Active participation in relevant industry organizations (e.g., PHUSE, CDISC), a plus.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees