Associate Director, Statistical Programming

Kailera

Waltham, MA, US
$159,000 - $195,000 usd; not specified; comprehens...
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Sas programming expertise
Cdisc standards
Regulatory submissions
** Kailera is seeking an Associate Director of Statistical Programming to lead statistical programming activities for clinical trials focused on obesity and related conditions. The role requires significant experience in clinical development, regulatory submissions, and expertise in SAS programming, with a strong preference for candidates with a background in late-phase trials. **

Job Summary

  • This role is responsible for leading statistical programming activities on assigned disease areas, supporting clinical trials, regulatory submissions, and other key initiatives.
  • Responsibilities include leading programming efforts, overseeing CRO activities for CDISC standards, SDTM, ADaM datasets, and TFLs, and conducting independent validation.
  • The company offers comprehensive health coverage, flexible time off, paid holidays, a year-end shutdown, a wellness stipend, 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, annual bonus opportunities, and equity grants.

Matching Summary

Match Score: 75

** Kailera is seeking an Associate Director of Statistical Programming to lead statistical programming activities for clinical trials focused on obesity and related conditions. The role requires significant experience in clinical development, regulatory submissions, and expertise in SAS programming, with a strong preference for candidates with a background in late-phase trials. **

Salary

$159,000 - $195,000 USD; Not specified; Comprehensive health coverage, flexible time off, paid holidays, year-end shutdown, wellness stipend, 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, annual bonus opportunities, equity grants

Skills & Requirements

Must-have

  • SAS programming expertise
  • CDISC standards
  • regulatory submissions
  • ICH/GCP guidelines
  • CRO oversight

Nice-to-have

  • cardiometabolic diseases experience
  • late-phase clinical trial support

Key Requirements

  • Minimum 8+ years of relevant experience with MS degree
  • Minimum 6+ years of relevant experience with PhD degree
  • Proven hands-on programming experience in clinical development
  • Experience in regulatory submissions (NDAs, BLAs)
  • Experience overseeing CROs

Work Rights

Not specified

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