Senior 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.

As the Senior Director of Biostatistics, you will lead and build the statistical team for the assigned disease area, ensuring that statistical strategies and methodologies align with clinical development objectives and regulatory expectations. In this critical leadership role, you will lead the development, execution, and interpretation of statistical analyses, ensuring data quality, analysis integrity, and compliance with regulatory standards. You will champion innovation in trial design and statistical methodology while fostering a collaborative and high-performing team culture. This role requires strong cross-functional leadership to influence clinical development strategy and decision-making, directly contributing to the success of the company’s goals. This role reports to the VP, head of biometrics.

Responsibilities:

• Build, mentor, and lead a high-performing statistical team within the assigned disease area, fostering a culture of collaboration, learning, and accountability.
• Serve as a core member of the clinical development team, providing strategic and statistical leadership in the development and execution of clinical development strategies by collaborating with cross-functional teams.
• Partner with medical, regulatory, pharmacovigilance, pharmacology, clinical operations, and other functions to ensure appropriate statistical methodologies and analysis plans are implemented across all clinical studies.
• Champion 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.
• Contribute to the development and implementation of functional Standard Operating Procedures (SOPs) and workflows, ensuring compliance with regulatory standards and alignment with industry best practices.
• Oversee CRO activities, ensuring quality deliverables, adherence to timelines, and efficient resource utilization.

Qualifications:

• Ph.D. in Biostatistics or Statistics with 10+ years of relevant industry experience, or Master’s degree with 12+ years of experience.
• Proven expertise in statistical activities supporting clinical development programs, including successful submissions of NDAs, BLAs, or other regulatory filings.
• Demonstrated leadership 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.
• Background in cardiometabolic disease or related therapeutic areas is preferred.
• Experience as a people manager is preferred.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

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