Biostatistics Director - Indication Lead

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Biostatistics Director – Indication Lead based in the United States.

This is a senior scientific leadership role within a fast-growing, innovation-driven biotech environment focused on transforming the treatment landscape for severe autoimmune diseases. The position carries end-to-end statistical leadership responsibility for a major clinical indication across multiple assets, playing a critical role in shaping development strategy from early phases through regulatory submission. You will act as the primary quantitative expert for the indication, influencing study design, regulatory strategy, and data interpretation across global programs. The role requires close collaboration with cross-functional stakeholders to ensure robust, high-quality statistical deliverables that support decision-making and regulatory success. You will also guide and mentor other statisticians while contributing to the evolution of advanced analytical approaches. This is a high-impact opportunity to directly influence clinical development strategy and bring innovative therapies closer to patients.

• Serve as the indication lead biostatistician, owning and driving all statistical activities across a major clinical indication spanning multiple assets.
• Lead the development and execution of the quantitative data strategy, ensuring alignment with overall clinical development and regulatory objectives.
• Oversee and deliver all statistical outputs across the indication, including contributions to global health authority submissions (e.g., BLA, NDA, MAA).
• Drive the design and application of innovative statistical methodologies and complex clinical trial designs across all development stages.
• Collaborate closely with cross-functional stakeholders, including clinical, regulatory, and program teams, to ensure high-quality and timely delivery of statistical deliverables.
• Guide and mentor a team of statisticians supporting multiple assets within the indication, fostering technical excellence and consistency.
• Ensure all statistical activities comply with internal standards, regulatory requirements, and industry best practices.
• Contribute to strategic decision-making by translating complex statistical insights into clear, actionable recommendations.

Requirements:

• 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, including regulatory submissions (BLA/NDA/MAA) and health authority interactions.
• Strong expertise in clinical trial design and advanced biostatistical methodologies, including innovative and complex approaches.
• Proficiency in statistical programming languages such as SAS and/or R.
• Strong ability to collaborate effectively with cross-functional teams and senior stakeholders in a matrixed environment.
• Excellent written and verbal communication skills, with the ability to clearly explain complex statistical concepts in English.
• Demonstrated leadership ability, including mentoring and guiding other statisticians.
• Ability to work autonomously while managing multiple priorities in a fast-paced, dynamic biotech environment.
• Strong problem-solving mindset with a focus on scientific rigor and delivery excellence.

Benefits:

• Competitive base salary ranging from $212,000 to $291,500 USD depending on experience and qualifications.
• Eligibility for 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 highly innovative, science-driven biotech environment focused on transformative therapies.
• Exposure to global clinical development programs and high-impact regulatory submissions.
• Strong emphasis on scientific innovation, collaboration, and professional development.
• Inclusive and dynamic workplace culture within a rapidly growing organization.