Associate Director, Statistical Programming


Brisbane, CA

This position is responsible for assisting in setting direction and function of the Statistical Programming Department. Additional responsibilities include managing the creation and validation of statistical programming deliverables: compliant SDTM and ADaM datasets, all associated submission deliverables, and the tables, figures, and listings as required for the analysis and reporting of clinical trial data. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

Essential Duties & Responsibilities

Assist in providing direction and function for the Statistical Programming department by providing feedback into process initiatives and implementation of published industry standards, recommendations for technology improvements, and opportunities for programmer growth and development.

Manage project deliverables (multiple projects), ensuring that timelines are met and expected quality is attained.

Manage team of 6-8 programmers; assign tasks, set priorities, manage workloads, review deliverables, evaluate performance on an on-going basis.

Perform programmer recruitment, liaise with HR to identify/screen candidates, perform interviews, and provide recommendations.

Train and/or mentor junior level programmers.

Liaise with Clinical, Data Management and Biostatistics for database and dataset specifications, timelines, and quality requirements, and other study requirements as necessary.

Create and validate SDTM and ADaM datasets and associated submission deliverables in compliance with published industry standards and project/study specific requirements.

Create and validate TFL output in compliance with study specific requirements.

Manage external vendors; review specifications.

Receive, import, and verify the structure of external data

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