Manager, Statistical Programming Operations (Hybrid)

Irvine, CA, United Statesfull time

On Site

senior

H1B: yes

AbbVie Manager, Statistical Programming Operations at AbbVie responsible for optimizing and deploying AI-focused business processes and technology solutions within Data and Statistical Sciences. This role partners with cross-functional experts to implement clinical data analysis ecosystems.

Responsibilities

Lead/Support the design and implementation of cross-functional solutions, business processes, associated technologies and end-to-end agentic AI solutions tailored for specific pharma use cases
Partner with senior stakeholders across the enterprise to identify business needs, translate them into opportunities, and manage project delivery.
Engage with multi-disciplinary experts to influence, elicit, analyze and document business requirements and translate 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.
Deliver optimization of end-to-end business processes that enable quality and efficiency such as 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 (e.g., FDA guidance on AI) to define future AI roadmaps. Evaluate and recommend upcoming industry trends, best practices and cutting-edge tools. Engage in external vendor assessment and provide recommendations.
Ensure that all implementations meet GxP 21 CFR Part 11, data privacy, and computer system validation (CSV) requirements and adhere to global and local agency regulations, good clinical practices (GCP), ICH guidelines, AbbVie standard operating procedures and functional quality standards.

Qualification

MS in StatisticsDemonstrated problem-solvingIntermediate-level proficiency in SASExperience with cloud platforms (AWSOther Required Skills

Required

MS in Statistics, Computer Science or a related field with 7+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 9+ years of relevant experience.
Experience leading and overseeing FSP 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, 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

Preferred

Degree in computer science or strong computer science fundamentals preferred.
Matrix Management and Project Management skills are desirable.
Experience with cloud platforms (AWS, Azure) and database systems (vector databases, SQL) is a plus
Programming certifications and proficiency in multiple programming languages are desirable.
Other Required Skills:
Ability to effectively communicate complex analytical and technical concepts with clarity, both written and oral to technical and non-technical personnel.
Ability to effectively represent Statistical Programming Operations in cross functional teams.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: