Director Biostatistics

We’re Hiring: Director, Biostatistics

Are you a strategic statistical leader ready to shape clinical development and bring life-saving therapies to patients? Our client is a global biopharma company looking for two Directors, Biostatistics to lead statistical strategy across clinical programs and drive excellence from study design through regulatory submission. As a global biotherapeutics leader, they develop innovative therapies across immunology, hematology, cardiovascular, metabolic, respiratory, and transplant medicine—leveraging cutting-edge platforms including plasma fractionation, recombinant protein technology, and cell & gene therapy.

About the Role

As Director, Biostatistics, you will lead the full scope of statistical contributions across the clinical development lifecycle from early planning to submission and beyond. You’ll partner closely with Clinical Development and cross-functional teams to ensure robust, high-quality data that maximizes program success. This is a high-impact, matrix leadership role where influence, collaboration, and scientific rigor are key.

What You’ll Do

• Define and drive statistical strategy across clinical development programs, including study design, analysis, and regulatory submissions
• Lead trial design and go/no-go decision criteria, ensuring scientifically sound and efficient development plans
• Provide strategic statistical input to optimize study execution and data integrity
• Translate complex statistical findings into clear clinical and business insights
• Oversee analysis delivery, including integrated analyses and reporting across trials
• Represent Biostatistics in interactions with global health authorities (FDA, EMA, PMDA), including defending strategies and leading regulatory responses
• Collaborate cross-functionally and serve as a key partner to Program Strategy Teams 
• Provide oversight of external partners, including CROs and FSP statisticians

What We’re Looking For

• MS or PhD in Statistics or a related field
• PhD 8+/MS 10+ years of experience in pharma/biotech clinical development
• Proven leadership in statistical strategy and regulatory submissions
• Strong experience interacting with global regulatory agencies
• Expertise in clinical trial design, CDISC standards, and statistical operations
• Ability to lead through influence in a matrix environment
• Exceptional communication skills with the ability to defend ideas and drive alignment 

Location & Travel

• Hybrid role (3 days onsite per week) in Greater Boston or Philadelphia
• Occasional travel to scientific conferences

If you’re passionate about advancing science, influencing strategy, and making a meaningful impact on patients worldwide, I’d love to connect.

Apply now or message me directly to learn more!

sdevine@penfieldsearch.com

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