Manager, Statistical Programming Operations (Hybrid)
AbbVie
Summary
AbbVie Data and Statistical Sciences (DSS) is responsible for bringing people, process, and technology together to generate business value from clinical data. 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.
Job description
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
- 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
Requirements
- 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
- 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
- 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
Benefits
- Paid Time Off
- Medical Insurance
- Dental Insurance
- Vision Insurance
- 401(k)
- Long-Term Incentive Programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.