Director, Statistical Programming - Immunology (Hybrid)

The Director, Statistical Programming is a key leadership role responsible for overseeing a team of both new and experienced programmers. They will be leading and managing the statistical programming team to ensure efficient and high-quality deliverables. This role will have a strong focus on multiple indications within a specific therapeutic area, ensuring that all programming activities align with the overall clinical development strategy. The Director will collaborate closely with cross-functional teams to provide strategic input and support decision-making processes. They will also be responsible for establishing and maintaining standard operating procedures to ensure compliance with regulatory requirements and industry best practices.

Responsibilities

Lead and manage the statistical programming team to ensure efficient and high-quality deliverables; Provide strategic input and support decision-making processes with cross-functional teams; Establish and maintain standard operating procedures to ensure compliance with regulatory requirements and industry best practices; SAS programming oversight and critical review of programming techniques and strategy; Set short and long term vision for programming standards and monitor regulatory trends; Provide strategic guidance on CRF and database design and global standards; Interpret statistical analysis plans and guide analysis data set specifications and submission programs; Manage stakeholders, priorities and resources across therapeutic areas and anticipate project problems with contingency plans; Present statistical programming concepts, risks and impacts to programmers, statisticians, scientists and non-scientists; Coach and mentor first line managers and staff, arrange training and career development; Manage staffing assignments, resource allocation and global resource planning support; Set high expectations and goals and foster open, honest communication

Requirements

MS in Statistics, Computer Science or a related field with 12+ years of relevant experience, OR BS in Statistics, Computer Science or a related field with 14+ years of relevant experience; Highly competent in SAS programming and Macro development; Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA; NDA/BLA or other regulatory filing experience, including ISS or ISE experience; A minimum of 5 yrs management experience required; Previous experience leading direct reports; High degree of technical competence and communication ability, both oral and written; Thorough understanding of ICH Guidelines and relevant regulatory requirements

Nice to have

Immunology Experience; Experience utilizing AI in statistical programming activities

Benefits

Paid time off (vacation, holidays, sick); Medical, dental and vision insurance; 401(k) for eligible employees; Eligibility for long-term incentive programs