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AbbVie

Global biopharmaceutical company developing medicines

Manager – Statistical Programming Operations

Business OperationsPosted on Nov 12
Full-timeIrvine, CA, USA

About the Job

Requirements

  • A Master of Science in Statistics, Computer Science, or a related field with at least 7 years of relevant experience, or a Bachelor of Science in those fields with at least 9 years of relevant experience.
  • Experience leading and overseeing functional service provider outsourced programming teams.
  • Demonstrated problem-solving, analytical, and multitasking skills, with a fundamental understanding of clinical research, statistical programming, CDISC standards, and CDISC-compliant submission requirements.
  • Fundamental understanding of various programming paradigms, IT system architectures, and agentic AI frameworks.
  • Intermediate-level proficiency in SAS, R, Python, shell scripting, or other programming languages.
  • Hands-on application development experience using SAS, R, and Python.
  • Ability to communicate complex analytical and technical concepts clearly, both orally and in writing, to technical and non-technical personnel.
  • Ability to effectively represent Statistical Programming Operations in cross-functional teams.

Responsibilities

  • Lead or support the design and implementation of cross-functional solutions, business processes, associated technologies, and end-to-end agentic AI solutions tailored to specific pharmaceutical use cases.
  • Partner with senior stakeholders across the enterprise to identify business needs, translate them into opportunities, and manage project delivery.
  • Engage with multidisciplinary experts to influence, elicit, analyze, and document business requirements, and translate them into technology functional requirements. Leverage project management tools and software development methodologies to manage resources, mitigate risk, and deliver on commitments.
  • Develop and maintain automation scripts, workflows, and tools using programming languages and AI frameworks, ensuring secure, scalable, and compliant solutions.
  • Optimize end-to-end business processes to enable quality and efficiency, including process maps, standard operating procedures, job aids, and work instructions.
  • Drive change management by conceiving and operationalizing innovation and facilitating adoption across teams. Conduct demos, training sessions, and knowledge-transfer activities.
  • Stay abreast of emerging technologies and regulatory guidelines, including FDA guidance on AI, to define future AI roadmaps. Evaluate and recommend industry trends, best practices, and tools. Engage in external vendor assessment and provide recommendations.
  • Ensure implementations meet GxP 21 CFR Part 11, data privacy, and computer system validation requirements, and adhere to global and local agency regulations, good clinical practices, ICH guidelines, AbbVie standard operating procedures, and functional quality standards.

Desired Qualifications

  • A degree in Computer Science or strong Computer Science fundamentals.
  • Matrix management and project management skills.
  • Experience with cloud platforms such as AWS and Azure, and database systems such as vector databases and SQL.
  • Programming certifications and proficiency in multiple programming languages.

About the Company

AbbVie

Global biopharmaceutical company developing medicines

AbbVie is a global biopharmaceutical company that develops and sells medicines to treat serious health conditions. Its portfolio spans immunology, oncology, virology, neuroscience, and aesthetics, with products designed to modulate the immune system, target disease pathways, or support medical aesthetics. AbbVie compounds its products through a heavy emphasis on research and development, investing billions to build a steady pipeline of new therapies. Its medicines are brought to market by selling to healthcare providers, hospitals, and clinics, and in some cases directly to patients via prescriptions. The company differentiates itself through a wide, globally distributed product line, substantial R&D investment, and a commitment to sustainability and patient care, including science-based targets. AbbVie’s goal is to improve patient outcomes by delivering effective treatments for unmet medical needs while pursuing long-term, responsible growth across healthcare markets.

Company size
10,001+
Company stage
IPO
Headquarters
North Chicago, IL
Founded
1888

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