Senior Director, Head of Statistical Programming

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.

We are seeking a highly experienced and visionary Head of Statistical Programming to lead and oversee statistical programming activities at. This is a pivotal leadership role responsible for managing all programming deliverables to support clinical development programs, regulatory submissions, and other key initiatives. The ideal candidate will build and lead a high-performing statistical programming team and drive operational excellence while ensuring compliance with regulatory standards and industry best practices. This role reports to the VP, head of biometrics.

Responsibilities:

• Build, lead, and mentor a high-performing statistical programming team to support clinical trials across all phases of development. Foster a collaborative, innovative, and learning-focused team culture to drive excellence and efficiency.
• Provide strategic direction and technical leadership for all programming activities.
• Oversee the development, validation, and delivery of clinical trial datasets (e.g., SDTM, ADaM) and statistical outputs (e.g., tables, listings, figures) to support clinical studies, regulatory submissions, and publications. Ensure adherence to CDISC standards and compliance with global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA).
• Establish and enforce programming standards, workflows, and quality control processes to ensure consistency, efficiency, and compliance. Ensure the timely and accurate delivery of programming deliverables to meet project milestones and regulatory requirements.
• Collaborate with biostatistics, data management, clinical operations, medical writing, and other cross-functional teams to ensure programming deliverables align with study and program objectives.
• Oversee and manage programming activities outsourced to CROs, ensuring high-quality deliverables and cost-effective resource utilization. Develop and manage the programming budget, ensuring alignment with organizational goals and priorities.
• 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.

Qualifications:

• MS in Biostatistics or Statistics with 12 + years of relevant experience, or PhD degree with 10+ years of experience.
• Proven expertise in hands-on programming activities in a leading role supporting clinical development programs.
• Proven track record of successful submissions of NDAs, BLAs, or other regulatory filings, including ISS or ISE experience.
• Proficiency in SAS programming. Extensive knowledge of ICH/GCP guidelines, CDISC standards, and regulatory submission requirements (e.g., FDA, EMA).
• Proven track record of managing multiple projects simultaneously and managing conflicting priorities.
• Extensive experience in qualifying and managing vendors.
• Experience as a people manager is required.
• Background in cardiometabolic disease or related therapeutic areas 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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