Associate Director, Programming Statistical Computing Environment (SCE)
The Antibody Society, Princeton, NJ, United States
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. 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.
Salary For US based candidates, the proposed salary band for this position is: $164,080.00 – $246,120.00. The actual salary offer will consider a wide range of factors, including skills, qualifications, experience, and location. Certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long‑term incentives.
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
Ideal Candidate
Genuinely passionate about our purpose
Brings precision and excellence to all that they do
Believes in our rooted‑in‑science approach to problem‑solving
Is a generous collaborator who can work in teams with a broad spectrum of backgrounds
Takes pride in enabling the best work of others on the team
Can grapple with the unknown and be innovative
Has experience working in a fast‑growing, dynamic company (or a strong desire to)
Works hard and is not afraid to have a little fun while doing 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 are in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
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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.
Salary For US based candidates, the proposed salary band for this position is: $164,080.00 – $246,120.00. The actual salary offer will consider a wide range of factors, including skills, qualifications, experience, and location. Certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long‑term incentives.
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
Ideal Candidate
Genuinely passionate about our purpose
Brings precision and excellence to all that they do
Believes in our rooted‑in‑science approach to problem‑solving
Is a generous collaborator who can work in teams with a broad spectrum of backgrounds
Takes pride in enabling the best work of others on the team
Can grapple with the unknown and be innovative
Has experience working in a fast‑growing, dynamic company (or a strong desire to)
Works hard and is not afraid to have a little fun while doing 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 are in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
#J-18808-Ljbffr