Director, Statistical Programming - Immunology (Hybrid)

AbbVie • Irvine, IL

2d • Hybrid

About The Position

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

The position provides strategic leadership across SAS programming, programming and database standards, case report form and database design, derivation programming, submission data sets and programs, stakeholder interactions, communication, training and mentoring, and resource management. It supports project delivery, staff development, regulatory readiness, and effective allocation of programming expertise and resources.

Requirements

• Master’s degree in Statistics, Computer Science, or a related field and 12 or more years of relevant experience, or a 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 experience with clinical trials, including familiarity with regulatory agency expectations, especially FDA and EMEA.
• Experience with NDA/BLA or other regulatory filings, 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

• Oversee and lead statistical programming staff to deliver efficient, high-quality work aligned with clinical development strategy.
• Review SAS programming techniques and strategies, identify limitations or flaws, and address them proactively.
• Monitor and interpret industry and regulatory trends and guidance; set short- and long-term programming standards that align with related functional standards.
• Provide strategic guidance on case report form development, database design, and global standards for CRFs and databases.
• Interpret statistical analysis plans and guide development of analysis data set specifications and submission data sets and programs.
• Manage priorities and resources with stakeholders across therapeutic areas, build relationships with external partners and service organizations, and anticipate project risks and develop contingency and escalation plans.
• Present programming concepts, risks, impacts, and recommendations effectively to technical and nontechnical audiences; plan and conduct meetings and presentations.
• Coach and mentor first-line managers, provide professional and technical leadership, arrange staff training, support career development, and ensure training compliance.
• Assign responsibilities, define scope, review progress, and allocate staff to projects to maintain the appropriate balance of expertise and experience and support timely, quality delivery.
• Assist the Global Director of Statistical Programming with global resource planning.
• Set high expectations and goals, lead staff toward organizational goals, and foster efficient execution and open, honest communication.

Benefits

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

What This Job Offers

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