Principal Statistical Programmer (Biotech)

TL;DR

Principal Statistical Programmer (Biotech): Leading clinical trial reporting and electronic submissions with an accent on SAS programming, CDISC standards, and regulatory compliance. Focus on solving complex data reporting challenges, mentoring team members, and collaborating with cross-functional departments to ensure high-quality clinical data deliverables.

Location: Must be based in the United States (Remote, Hybrid, or On-Site options available).

Salary: $149,200 - $223,800

Company

A global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Lead statistical programming activities for clinical sub-teams and manage project deliverables.
• Develop and validate SAS code for clinical trial reporting, including ISS/ISE and eCTD submissions.
• Perform quality control checks on programming outputs to ensure accuracy and consistency.
• Collaborate with biostatisticians, data management, and senior management to support submission-related activities.
• Provide technical leadership and mentorship to team members while ensuring compliance with FDA/ICH/GCP regulations.
• Participate in cross-functional teams to improve processes, system validation, and tool integration.

Requirements

• Bachelors degree in a scientific discipline.
• 8+ years of experience in biotech, pharmaceuticals, or clinical research for B.S. holders (5+ years for M.S. or higher).
• Proficiency in SAS language, including Macro, BASE SAS, SAS/STAT, and SAS/GRAPH.
• Intermediate knowledge of CDISC standards and clinical trial reporting.
• Experience with regulatory submissions and eCTD format.
• Must be authorized to work in the United States.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with company matching.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Educational assistance programs and student loan repayment support.
• Flexible work arrangements including remote, hybrid, and on-site options.
• Commuting subsidies and charitable donation matching.