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Associate Director, Programming Statistical Computing Environment; SCE
Job in
Scranton, Lackawanna County, Pennsylvania, 18512, USA
Listed on 2026-03-02
Listing for:
Genmab
Full Time
position Listed on 2026-03-02
Job specializations:
-
IT/Tech
Data Analyst, Data Security
Job Description & How to Apply Below
Employer Industry
Biotechnology
Why consider this job opportunity:- Salary up to $
- Opportunity for career advancement and growth within the organization
- Comprehensive health benefits including medical, dental, and vision insurance
- Generous time-off policies including paid vacation, sick leave, and 12 weeks of paid parental leave
- Support resources for family care, financial wellness, and emotional well-being
- Flexible working environment with options for remote work
- Serve as Business System Owner for the Statistical Computing Environment, ensuring compliance and validation
- Lead validation lifecycle activities, including user acceptance testing and change impact assessments
- Manage vendor-driven system releases and changes, ensuring proper documentation and risk evaluation
- Conduct periodic system reviews to confirm compliance posture and fitness for intended use
- Partner with IT and QA on vendor oversight and audit documentation for the SaaS platform
- 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
- Proven experience as Business or Application System Owner for a GxP platform
- Strong working knowledge of 21 CFR Part 11, GxP SDLC, and data integrity principles
- Experience with inspection readiness and regulatory audits
- Practical knowledge of statistical programming environments (e.g., SAS, R)
- Experience in a vendor-based validation model
- Active participation in relevant industry organizations (e.g., PHUSE, CDISC)
- Knowledge of open-source package governance and reproducible environment strategies
- Strong analytical and organizational skills with the ability to manage competing priorities
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Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
Position Requirements
10+ Years
work experience
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