Director, Statistical Programming - Immunology (Hybrid)

AbbVie•South San Francisco, CA

2d•$160,500 - $305,000•Hybrid

About The Position

The Director, Statistical Programming is a leadership role overseeing a team of new and experienced programmers. The Director leads and manages the statistical programming team to deliver efficient, high-quality work, with a focus on multiple indications within a therapeutic area and alignment with the overall clinical development strategy. This role collaborates with cross-functional teams, provides strategic input to decision-making, and establishes and maintains standard operating procedures to support regulatory compliance and industry best practices. The Director provides leadership across SAS programming, programming standards, database and case report form design, derivation programming, submission data sets and programs, stakeholder relationships, communication, staff training and mentoring, and resource management. The role also sets expectations and goals, promotes efficient execution, and encourages open and honest communication.

Requirements

Master’s degree in Statistics, Computer Science, or a related field and 12 or more years of relevant experience; alternatively, a bachelor’s degree in one of these fields and 14 or more years of relevant experience.
High competence in SAS programming and macro development.
Pharmaceutical clinical-trial experience, 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, lead, and manage a statistical programming team to ensure efficient, high-quality deliverables.
Apply extensive knowledge of SAS programming concepts and techniques, critically review programming approaches, and proactively identify and correct flaws.
Monitor and interpret industry and regulatory trends and guidance; set short- and long-term visions for programming standards and ensure alignment with related functions’ standards.
Provide strategic guidance on case report forms, database definitions, and global CRF and database design standards.
Interpret statistical analysis plans and develop analysis data set specifications for derivation programming and submission data sets and programs.
Collaborate with stakeholders to manage priorities and resources across therapeutic areas, build relationships with external partners and service organizations, and apply an understanding of drug development principles.
Anticipate project issues, develop contingency plans, and create escalation plans to resolve issues at therapeutic and project levels.
Persuasively communicate statistical programming concepts, risks, impacts, and recommendations to programmers, statisticians, scientists, and non-scientists; plan and deliver meetings and presentations.
Coach and mentor first-line managers as needed, provide professional and technical leadership, arrange staff training and career development opportunities, ensure training consistency, and maintain training compliance.
Assign staff responsibilities, define project scope, review progress, and allocate resources to balance expertise and experience and deliver projects on time with suitable quality.
Assist the Global Director of Statistical Programming with global resource planning.
Establish high expectations and goals, lead staff to meet or exceed them, support efficient organizational execution, and encourage open and honest communication.