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 statistical support for both early- and 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. Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month). Responsibilities: Lead statistical efforts for early-to-late phase clinical studies, key regulatory, and submission activities Provide statistical leadership in the development and execution of clinical development strategies by collaborating with cross-functional teams 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 Strong leadership in statistical activities supporting clinical development programs Participated in implementing innovative statistical methodologies to enhance clinical trial efficiency and effectiveness Hands-on expertise with statistical software (e.g., SAS, R) 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 Education: PhD/MS in Biostatistics or Statistics Salary Range $204,000 $245,000 USD For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us. 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 ... (truncated, view full listing at source)