Kailera is a late clinical-stage biotechnology company advancing a diversified pipeline of GLP-1 therapies to provide options for people living with obesity. Backed by a16z.
About the role
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)
What they're looking for
- 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
More about this role
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 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)
- 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...
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