AbbVie→
Manager, Statistical Programming Operations… at AbbVie · Irvine
Job Description
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
AbbVie Data and Statistical Sciences (DSS) is the best-in-class organization within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical data. Our operational model is exemplified through execution and innovation.
The Manager of Statistical Programming Operations is responsible for optimizing and deploying business processes and technology solutions primarily focused on Artificial Intelligence adoption within DSS in support of the AbbVie portfolio. A technical and innovative role who effectively interfaces and partners with statistical programming, data analytics, data standards, biostatistics, clinical data management and information technology experts to implement next generation clinical data analysis ecosystem.
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.
Qualifications
Minimum Qualifications:
- 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 Qualifications:
- 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.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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https://www.abbvie.com/join-us/reasonable-accommodations.html