Director, Statistical Programming

Duties and Responsibilities

• Lead and manage statistical programming activities for clinical studies, ensuring statistical programming deliverables are delivered within timelines and with high quality and cross-study consistencies.
• Collaborate with Biostatisticians in the creation, implementation, and maintenance of programming for each study, accounting for timelines, resources, and quality deliverables; ensure programming has been carried out per industry and internal standard practice.
• Collaborate with Data Management to implement the CDISC standard at the CRF and database build-up stage; review annotated case report forms.
• Provide technical leadership and guidance to the programming team and vendors around project conventions, standards, best practices, and specifications.
• Provide support in the production/validation of SDTM, ADaM, summary tables, and figures.
• Manage oversight of contractors and CROs.
• Manage statistical programming support of potential FDA/EMEA regulatory submissions, following CDISC standards.
• Contributes to the departmental process.

Requirements and Qualifications

• A minimum of 12+ years of experience in statistical programming and analysis of clinical trial data with demonstrated increasing responsibility.
• Experience programming for and contributing to an NDA or BLA submission preferred.
• Experience working with CROs.
• Masters degree or above in statistics, data science/analytics, computer science, or other relevant scientific field.
• At least 5 years of management experience

Pay

USD103 - USD115 per hour

Schedule

Hybrid Role