Director of Biostatistics

For our client, we are seeking a Director of Biostatistics to join the team of a leader in the Pharmaceuticals & Biotech space. This role will shape statistical strategy across clinical development programs, ensuring rigorous design, analysis, and interpretation of trial data. You will partner closely with cross-functional teams, regulatory stakeholders, and external vendors to keep studies aligned with development goals.

The position also plays a key role in authoring key documents, supporting submissions, and helping advance programs through the clinical and regulatory process.

Location:

Remote

Compensation: $213,000 – $240,000 annually

• Lead statistical strategy for clinical development programs in collaboration with cross-functional teams
• Plan and track biostatistics timelines and deliverables, ensuring quality and timely completion
• Independently author and review protocols, statistical analysis plans, and clinical study reports
• Provide statistical input for data management and programming to align with study objectives
• Develop statistical programs for ad-hoc analyses, manuscripts, and presentations
• Write statistical sections of regulatory documents and support regulatory strategy
• Participate in the assessment and oversight of CROs within the area of responsibility

• Ph.D. in Biostatistics, Statistics, or a related field with 7+ years of clinical trial experience, or a Master’s with 10+ years of experience
• Strong expertise in statistical methodologies for clinical trial design and analysis
• Proven ability to lead cross-functional teams and mentor junior statisticians
• Familiarity with clinical trials that have high placebo response rates
• Experience in Immunology and Inflammation is highly desirable
• Knowledge of FDA/EMA regulations and ICH‑GCP guidelines
• Expertise in CDISC standards and SAS programming; R knowledge is a plus

• Opportunity to impact the development of new medicines in a vibrant startup culture
• Supportive and inclusive team environment that values authenticity
• Competitive salary and benefits package
• Professional growth and development opportunities

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.