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Associate Director, Statistical Programming

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Kailera Therapeutics

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Location:
United States , Waltham

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Contract Type:
Not provided

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Salary:

160000.00 - 200000.00 USD / Year

Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • Minimum of 7+ years of relevant experience with MS
  • 5+ years of relevant experience with PhD
  • 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
  • Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field

Nice to have:

Background in cardiometabolic diseases or related therapeutic areas is preferred

What we offer:
  • Comprehensive health coverage
  • Flexible time off
  • Paid holidays
  • Year-end shutdown
  • Monthly wellness stipend
  • Generous 401(k) match
  • Tuition reimbursement
  • Commuter benefits
  • Disability and life insurance
  • Annual bonus opportunities
  • Equity grants

Additional Information:

Job Posted:
January 03, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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