Director, Statistical Programming - Immunology (Hybrid)

AbbVie • North Chicago, IL

2d • Hybrid

About The Position

The Director, Statistical Programming is a leadership role responsible for managing a team of new and experienced programmers and ensuring efficient, high-quality deliverables. The role focuses on multiple indications within a therapeutic area and aligns statistical programming activities with the overall clinical development strategy. It collaborates with cross-functional teams to provide strategic input and support decision-making, and establishes and maintains standard operating procedures that support compliance with regulatory requirements and industry best practices.

The Director oversees programming standards and strategy, database and case report form design guidance, derivation programming, submission data sets and programs, stakeholder relationships, staff development, and resource allocation. The position also assists the Global Director of Statistical Programming with global resource planning.

Requirements

• Master’s degree in Statistics, Computer Science, or a related field and 12 or more years of relevant experience, or bachelor’s degree in one of these fields and 14 or more years of relevant experience.
• Highly competent in SAS programming and macro development.
• Pharmaceutical clinical-trial experience, including familiarity with regulatory agency expectations, especially FDA and EMEA.
• NDA/BLA or other regulatory filing experience, including ISS or ISE experience.
• At least 5 years of management experience.
• Previous experience leading direct reports.
• High degree of technical competence and oral and written communication ability.
• Thorough understanding of ICH Guidelines and relevant regulatory requirements.

Nice To Haves

• Immunology experience.
• Experience utilizing AI in statistical programming activities.

Responsibilities

• Lead and manage statistical programming staff to deliver projects on time and with suitable quality.
• Provide strategic guidance on programming techniques, programming standards, case report forms, database designs, and global standards.
• Monitor and interpret industry and regulatory trends and guidance; set short- and long-term visions for programming standards and coordinate them with related functions’ standards.
• Interpret statistical analysis plans and develop analysis data set specifications; oversee derivation programming, submission data sets, and programs.
• Manage priorities and resources across therapeutic areas and build relationships with external partners and service organizations.
• Anticipate project and cross-project problems, develop contingency plans, create escalation plans, and provide strategic guidance to resolve issues.
• Present statistical programming concepts, risks, impacts, and recommendations to programmers, statisticians, scientists, and non-scientists; plan and conduct meetings and presentations.
• Coach and mentor first-line managers, provide technical and professional leadership, arrange staff training, and support staff career development.
• Ensure staff training opportunities are consistent and that self and staff comply with training requirements.
• Assign responsibilities, define scope, review activities and progress, and allocate project resources to maintain an appropriate balance of expertise and experience.
• Assist the Global Director of Statistical Programming in preparing global resource planning.
• Set organizational goals and expectations, lead staff toward meeting or exceeding them, and encourage efficient execution and open, honest communication.
• Establish and maintain standard operating procedures to support regulatory compliance and industry best practices.

Benefits

• Paid time off, including vacation, holidays, and sick time.
• Medical insurance.
• Dental insurance.
• Vision insurance.
• 401(k).
• Eligibility to participate in long-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Director