Associate Director, Clinical Pharmacology Data Programming Specialist

The Associate Director, Clinical Pharmacology Data Programming Specialist will provide technical expertise and project leadership for data programming, data management, and quality-control activities supporting clinical pharmacology and pharmacometrics across Genmab’s development portfolio.

The role combines hands-on programming with project coordination, including delivery of high-quality analysis-ready data and quantitative outputs, planning timelines, defining programming and QC approaches, and partnering with clinical pharmacologists, pharmacometricians, Clinical Programming, Data Management, Biostatistics, Bioanalytics, Biomarkers, and external vendors.

Work arrangement: This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.

Key Responsibilities

Pharmacometrics and Clinical Pharmacology Programming

·       Lead or support programming and QC of analysis-ready datasets and outputs for population PK, exposure-response, PK/PD, NCA, modeling and simulation, immunogenicity, biomarker, and related quantitative analyses.

·       Develop, maintain, and QC NONMEM-ready and other pharmacometric analysis datasets.

·       Integrate and pool clinical, dosing, PK, PD, immunogenicity, biomarker, efficacy, safety, laboratory, SDTM, ADaM, and other relevant data across studies.

·       Develop and maintain programming specifications, derivation rules, analysis datasets, tables, figures, listings, and exploratory outputs.

·       Provide programming support for data-driven analyses, health-authority requests, publications, conference presentations, and other CPQS deliverables.

Programming Quality Control and Validation

·       Perform independent QC of analysis datasets, derivations, programs, tables, figures, listings, and other quantitative outputs using a developer-reviewer model where appropriate.

·       Develop validation plans and QC strategies based on the intended use and regulatory importance of the analysis.

·       Design, test, validate, and document programming logic and reusable analytical workflows, ensuring traceability, reproducibility, and appropriate version control.

·       Develop automated and reusable data checks and QC tools to improve consistency and efficiency.

Project Coordination and Delivery

·       Plan and coordinate programming activities, milestones, and deliverables across one or more development programs in alignment with project and regulatory timelines.

·       Work with CPQS scientists to define data and programming requirements and identify risks related to scope, data availability, timelines, or deliverables.

·       Prioritize requests and support rapid-turnaround and ad hoc analyses when required.

·       Contribute to resource planning and scalable programming strategies as the CPQS portfolio grows.

Regulatory and Submission Support

·       Provide programming and QC support for clinical pharmacology components of regulatory submissions, including future BLA/sBLA and other global submissions.

·       Support preparation and QC of datasets, analyses, tables, figures, and supporting documentation for clinical pharmacology reports, Module 2.7.2, and related submission deliverables.

·       Provide rapid programming support for health-authority requests and other regulatory questions.

Standards, Automation, and Innovation

·       Contribute to CPQS programming standards, templates, libraries, reusable workflows, and automation of routine data preparation, reconciliation, QC, and reporting.

·       Support development, testing, validation, and maintenance of internal analytical tools, including R/Shiny and other quantitative applications.

·       Apply modern programming, data-science, and appropriate AI-assisted approaches while maintaining required validation, documentation, and independent QC.

·       Provide technical guidance and mentoring to colleagues as appropriate.

Qualifications

·       Master’s degree in Statistics, Biostatistics, Computer Science, Mathematics, Engineering, Pharmaceutical Sciences, Life Sciences, or a related quantitative discipline; Bachelor’s degree with substantial relevant experience may also be considered.

·       A minimum of 3 + years of experience with an advanced degree or 5+ years of experience with a bachelor’s degree of relevant programming experience in biotechnology, pharmaceutical, or related clinical development, with strong experience working with clinical-trial and clinical pharmacology data required.

·       Experience integrating complex clinical datasets across studies and knowledge of SDTM, ADaM, CDISC standards, and clinical-development data structures is required.

·       Strong programming skills in R and/or SAS are required; Python experience is desirable.

·       Experience developing and QC’ing analysis datasets, tables, figures, listings, and regulatory deliverables, with strong understanding of validation, traceability, and reproducibility is required.

·       Experience supporting population PK, exposure-response, PK/PD, NCA, or related pharmacometric analyses is preferred.

·       Familiarity with NONMEM, PsN, Phoenix WinNonlin, Monolix, or related pharmacometric software is desirable.

·       Experience supporting regulatory submissions and health-authority requests is preferred.

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 

Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process