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
Oversee a team of new and experienced programmers; Lead and manage the statistical programming team to ensure efficient and high-quality deliverables; Provide strategic input and support decision-making 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; Provide strategic guidance on CRF and database design; Interpret statistical analysis plans and develop analysis data set specifications; Manage priorities and resources across therapeutic areas and build relationships with external partners; Create escalation and contingency plans; Present statistical programming concepts and risks to stakeholders; Provide coaching, mentoring and training to staff and first line managers; Manage resource allocation and 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
Benefits
Paid time off (vacation, holidays, sick); Medical/dental/vision insurance; 401(k) for eligible employees; Eligibility for long-term incentive programs
Stany Zjednoczone · Florham Park
