Director, Biostatistics

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

As the Director of Biostatistics, you will lead the statistical support for late-phase clinical studies, ensuring that statistical strategies and methodologies align with clinical development objectives and regulatory expectations. In this critical role, you will lead the development, execution, and interpretation of statistical analyses, ensuring data quality, analysis integrity, and compliance with regulatory standards. This role requires strong statistical and cross-functional leadership to influence clinical development strategy and decision-making, directly contributing to the success of the company’s goals.

Responsibilities:

• Lead statistical efforts for late-phase clinical studies and submission activities
• Lead integrated safety analysis
• Provide statistical leadership in the development and execution of clinical development strategies by collaborating with cross-functional teams
• Lead the collaboration with medical, regulatory, pharmacovigilance, pharmacology, clinical operations, and other functions to ensure appropriate statistical methodologies and analysis plans are implemented across all clinical studies
• Lead the development and the adoption of innovative statistical approaches (e.g., adaptive, seamless, Bayesian designs) to enhance trial efficiency, optimize resource utilization, and increase the probability of success
• Ensure the accuracy, integrity, and consistency of statistical analyses across all clinical development programs, from Phase I through regulatory submissions and post-approval activities
• Oversee CRO activities, ensuring quality deliverables, adherence to timelines, and efficient resource utilization

Required Qualifications:

• Advanced degree (PhD/MS) in Biostatistics or Statistics
• PhD: Minimum of 8+ years of relevant experience
• MS: Minimum of 10+ years of relevant experience
• Successful experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE
• Strong leadership in statistical activities supporting clinical development programs and late-phase clinical trials
• Participated in implementing innovative statistical methodologies to enhance clinical trial efficiency and effectiveness
• Hands-on expertise with statistical software (e.g., SAS, R, Python) and familiarity with CDISC standards
• Strong problem-solving and strategic thinking skills, with the ability to translate complex statistical concepts into actionable insights for diverse stakeholders
• Excellent communication and interpersonal skills, with the ability to influence decision-making and foster collaboration across functions
• Extensive leadership experience in overseeing CRO activities

Preferred Qualifications:

• Experience as program-level safety statistics lead

Education:

• Advanced degree (PhD/MS) in Biostatistics or Statistics

Benefits of Working at Kailera

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

• Comprehensive health benefits and tax-advantaged savings accounts
• Flexible time off, 13 paid holidays, and a companywide year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Disability and life insurance