Associate Director, Programming

GenmabPlainsboro Township, NJ
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! Associate Director – Analysis Data Standards The Associate Director – Analysis Data Standards is a technical leader within the Programming Standards and Technology organization who owns the Analysis Data (ADaM) Standards capability, leading strategy, design, development, and maintenance of analysis data standard definitions and technology solutions. This role provides deep technical mentorship, resolves complex issues, and ensures smooth adoption of new standards, processes, and technologies. The Associate Director partners with governance bodies, contributes to enterprise strategy, and maintains strong industry awareness to advance programming innovation and excellence.

Requirements

  • 10+ years of relevant experience in the Pharmaceutical/Biotech Industry.
  • Bachelor’s or Master’s degree in statistics, biostatistics, computer science, or a related field.
  • Skilled SAS programmer with strong knowledge of CDISC ADaM models, efficient coding practices, and contextual understanding of clinical data.
  • Knowledge and experience leading the development of dynamic, reusable code.
  • Understanding of metadata-driven automation frameworks and their application to scalable ADaM creation.
  • Practical experience applying SDLC to the development, maintenance, and validation of standard code.
  • Analytical, thorough, and proactive, with the ability to manage multiple tasks independently while maintaining high quality and accountability.

Nice To Haves

  • Active participation in industry organizations (e.g., CDISC, PHUSE), including contributing to working groups or standards discussions, a plus.

Responsibilities

  • Own one or more enterprise capabilities within Programming Standards and Technology from concept to global rollout—defining roadmap, architecture, and implementation strategy, including change management.
  • Lead the development and lifecycle management of ADaM standards, implementation guidance, and enabling technology components.
  • Accountable for driving execution of project-based initiatives and operational goals, ensuring solutions are aligned with internal business needs, external requirements, and industry best practices.
  • Collaborate with the Programming Leadership Team (LT) and standards governance forums to identify priorities, pilot opportunities, and monitor adoption of capabilities.
  • Provide technical direction and mentorship to supporting subject matter experts (SMEs), resolving complex programming or implementation challenges.
  • Represent Statistical Programming in cross-functional governance and decision-making forums to maintain visibility and alignment with partner functions (i.e. Biostatistics, Data Management, IT, QA).
  • Continuously improve processes, standards, and technology by staying abreast of evolving global regulatory requirements and industry trends.
  • Oversee regulatory compliance (e.g., 21 CFR Part 11) through effective governance, ensuring systems and documentation remain audit-ready for GxP operations.
  • Provide support for cross-pillar projects and operational needs across the Standards and Technology portfolio including compliance and operational reporting, system validation, audit/inspection support for clinical programs and technology platforms.

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
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