Principal Statistical Programmer - Remote

Overview

The Principal Statistical Programmer is responsible for supporting the statistical programming efforts for a compound program, including developing, testing, maintaining, validating, and documenting SAS programs. This role involves providing technical expertise for the development of SAS programming standards and procedures.

In Short

• Ensure departmental training plans are in place and appropriate.
• Perform vendor qualifications regarding statistical programming functions.
• Generate, validate, and review SDTM domains and ADaM datasets.
• Generate, validate, and review tables, figures, and listings for clinical trials.
• Perform quality control for SAS programs and study documents.
• Maintain auditable documentation of all programming activities.
• Manage datasets and output consistency across studies.
• Provide statistical programming support for exploratory analyses.
• Develop and maintain departmental procedures and standards.
• Train and mentor new members and supervise contract programmers.

Requirements

• Proficiency in SAS programming.
• Experience in statistical analysis and clinical trials.
• Strong understanding of regulatory submissions.
• Ability to manage datasets and ensure quality control.
• Experience in training and mentoring team members.
• Knowledge of 21 CFR Part 11 compliance.
• Excellent documentation skills.
• Ability to manage vendor relationships and CRO activities.
• Strong organizational and communication skills.
• Experience with statistical programming standards.

Benefits

• Opportunity to work in a leading company in rare disease.
• Professional development and training opportunities.
• Collaborative and supportive work environment.
• Competitive salary and benefits package.
• Engagement in meaningful work that impacts patients' lives.