Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.
Job Description
Director, Statistical Programming
in Redwood City, California
Overview Director, Statistical Programming Direct Hire Full-Time Role Pay Rate:
$103 - $115 per hour
Location:
Redwood City, CA -
Remote Role Job Summary:
The Director of Statistical Programming will have primary responsibility for the planning, execution, and completion of all statistical programming activities.
Duties and Responsibilities:
Lead and manage statistical programming activities for clinical studies, ensure 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.
Other duties as assigned
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.
Master's degree or above in statistics, data science/analytics, computer science, or other relevant scientific field.
At least 5 years of management experience Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s