Associate Director Statistical Programming

Associate Director, Statistical Programming

We're seeking an Associate Director of Statistical Programming to lead statistical programming activities for clinical development programs and manage vendor oversight. This role will collaborate closely with Biostatisticians, data managers, and cross-functional teams, and will be an in-house expert in programming and data standards.

Key Responsibilities:

• Lead and manage programming for clinical trials, ensuring quality and adherence to timelines.
• Collaborate on programming strategies and support regulatory submissions.
• Develop and maintain analysis datasets, tables, and figures following CDISC standards.
• Provide technical guidance to cross functional teams and vendors.
• Stay current with industry trends and introduce innovative solutions.

Requirements:

• MS in Statistics, Computer Science, Life Sciences or related field with 8+ years of experience in statistical programming.
• Expert in SAS programming and macro development.
• Familiarity with ICH guidelines, CDISC standards, and regulatory requirements. Oncology experience preferred.
• Extensive experience in early-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, listings and figures
• Experience in NDA/BLA or other regulatory filings.
• Strong communication, and organizational skills.

Boston, Massachusetts, United States