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

Provide leadership and management of the statistical programming team to ensure efficient and high-quality deliverables; Focus on multiple indications within a specific therapeutic area, aligning programming activities with the clinical development strategy; Collaborate with cross-functional teams to provide strategic input and support decision-making; Establish and maintain standard operating procedures to ensure regulatory compliance and industry best practices; Review SAS programming techniques and strategy, correcting flaws proactively; Monitor and interpret industry/regulatory trends and set short and long term programming standards vision; Provide strategic guidance on CRF and database design and global standards; Interpret statistical analysis plans and develop analysis data set specifications; Manage stakeholders, priorities and resources across therapeutic areas, anticipating problems and creating contingency and escalation plans; Present statistical programming concepts, risks and impacts to varied audiences; Provide coaching, mentoring and training opportunities for staff; Manage staff assignments, scope, progress and resource allocation; Assist the Global Director of Statistical Programming with global resource planning; 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; Demonstrated extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry

Benefits

Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) for eligible employees; eligibility for long-term incentive programs