Director of Statistical Programming - Remote

Overview

The Director, Statistical Programming will provide leadership to the team for the submission readiness of study data packages per CDISC standards and FDA guidance, planning, execution, and quality of statistical analyses, and statistical programming. This position will report into the Head of Statistical Programming and will interact regularly with internal and external biostatisticians, clinical data managers, and other team members.

In Short

• Lead on develop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory review.
• Adopts strategic approach to producing and prioritizing analytical deliverables.
• Generate or validate ADaM datasets and TFLs, reviewer’s guide, and define files.
• Manage on-time and quality delivery for both in-house and outsourced projects.
• Work with data management to review case report forms and database specifications.
• Excellent experience with CDASH and CDISC data standards.
• Perform stakeholder management, negotiating timelines and scope of deliverables.
• Provide leadership or project management to major data-heavy study or project team deliverables.
• Lead statistical programming standards development and process improvements activities.
• May manage/mentor statistical programming staff if needed.

Requirements

• Bachelor’s or master’s degree in a data science field.
• Minimum 12+ years of biotechnology or pharmaceutical experience.
• Good experience in a leadership position and team management.
• Excellent Programming experience in SAS is a must.
• Experience managing delivery of statistical programming projects.
• In-depth knowledge in the analysis of clinical trial data.
• Familiar with regulatory agency expectations.
• Demonstrated ability to rapidly adapt to changing projects.
• Interest in continuing education in business knowledge and technology trends.
• Takes a fit-for-purpose mindset to daily work.

Benefits

• Competitive market-based salary.
• Opportunity to participate in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.
• Equal Opportunity Employer.