Biostatistics Director (Biotech)

TL;DR

Biostatistics Director (Biotech): Leading end-to-end statistical strategy for clinical indications in autoimmune disease research with an accent on regulatory submissions and complex trial design. Focus on driving quantitative data strategy, mentoring statistical teams, and ensuring high-quality deliverables for global health authority interactions.

Location: Must be based in the United States

Salary: $212,000–$291,500 USD

Company

A fast-growing, innovation-driven biotech organization focused on transforming the treatment landscape for severe autoimmune diseases.

What you will do

• Own and drive all statistical activities across a major clinical indication spanning multiple assets.
• Lead the development and execution of quantitative data strategy aligned with clinical and regulatory objectives.
• Oversee statistical outputs for global health authority submissions including BLA, NDA, and MAA.
• Design and apply innovative statistical methodologies and complex clinical trial frameworks.
• Collaborate with cross-functional stakeholders to ensure high-quality, timely delivery of statistical insights.
• Mentor and guide a team of statisticians to foster technical excellence and consistency.

Requirements

• Must be based in the United States
• Master’s degree or PhD in Statistics, Biostatistics, or a related field.
• Minimum of 7+ years of experience in the pharmaceutical or biotech industry.
• Proven track record of leading statistical strategy for clinical programs and regulatory submissions.
• Strong expertise in clinical trial design and advanced biostatistical methodologies.
• Proficiency in statistical programming languages such as SAS and/or R.
• Excellent communication skills with the ability to explain complex concepts in English.

Culture & Benefits

• Competitive base salary with short-term and long-term incentive programs.
• Comprehensive health, dental, vision, life, and disability insurance coverage.
• Retirement savings plan with employer contributions.
• Opportunity to work in a science-driven environment focused on transformative therapies.
• Exposure to global clinical development programs and high-impact regulatory submissions.
• Inclusive and dynamic workplace culture.