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.

We are seeking experienced programmers to join us as an Associate Director of 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.

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.
• 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.

Qualifications:

• Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field.
  • MS: Minimum of 10+ years of relevant experience.
  • PhD: Minimum of 8+ years of relevant experience.
• Proven hands-on experience in programming for clinical development, preferably in a leadership role, with a strong preference for late-phase clinical trial support.
• Demonstrated success 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.
• Background in cardiometabolic diseases 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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