Associate Director, 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.

What You’ll Do:

We are seeking an experienced programmer to join us as Associate Director, Statistical Programming. This is a critical role responsible for leading statistical programming activities on the assigned disease area(s). This role will support clinical trials, regulatory submissions, and other key initiatives.

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 programming efforts for clinical studies, including the development and review of programming specifications to ensure clarity, integrity, and compliance with internal and external standards
• Lead the execution of ad-hoc and post-hoc analyses to support emerging clinical questions, publications, and internal decision-making
• Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables
• Conduct independent validation and quality checks of statistical programming deliverables from CROs
• Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner
• Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines

Required Qualifications:

• Proven hands-on experience in programming for clinical development, preferably in a leadership role, with a strong preference for late-phase clinical trial support
• Experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE highly desirable
• Expertise in SAS programming and comprehensive knowledge of CDISC standards
• Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)
• Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables

Preferred Qualifications: