Lead, Scientific Programming—CDISC & Submissions

Jobtailor

Massachusetts

On-site

USD 140,000 - 190,000

Full time

14 days+

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Job summary

Jobtailor seeks a senior statistical programmer to lead and hands-on deliver high-quality programming outputs for global studies, ensuring regulatory compliance and standardization across analyses.

The role requires 7+ years of SAS or R programming, CDISC SDTM/ADaM expertise, and experience coordinating with vendors and cross-functional teams. Fluency in English is essential, with additional languages a plus.

Qualifications

  • Bachelor's degree required in a quantitative or health science field.
  • 7+ years hands-on SAS or R programming experience.
  • Proficiency with CDISC standards (SDTM/ADaM) and regulatory submission requirements.
  • Experience coordinating and delivering study/programming assets in a global setting.
  • Experience managing third party vendors and outsourcing relationships.
  • Experience driving automation and digital transformation initiatives.
  • Fluent in English; additional languages a plus.

Responsibilities

  • Provide leadership and hands-on support for programming deliverables to ensure quality and regulatory compliance.
  • Plan and track programming activities, timelines and resources globally.
  • Maintain standardization and consistency of specifications across studies and analyses.
  • Lead regulatory submission activities, ensuring CDISC data packages meet health authority expectations.
  • Oversee outsourcing engagements and coordinate with external vendors.
  • Collaborate with project statisticians and cross-functional teams in meetings.
  • Support process improvements and outsourcing operation management.
  • Mentor junior staff in programming techniques and standards.

Skills

SAS Programming
R Programming
CDISC Standards
Regulatory Submissions
Project Management

Education

Bachelor's degree in Statistics, Mathematics, Computer Science or related health sciences field

Job description

Jobtailor seeks a senior statistical programmer to lead and hands-on deliver high-quality programming outputs for global studies, ensuring regulatory compliance and standardization across analyses.

The role requires 7+ years of SAS or R programming, CDISC SDTM/ADaM expertise, and experience coordinating with vendors and cross-functional teams. Fluency in English is essential, with additional languages a plus.

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