Senior Manager, Statistical Programming — Remote (US)

Travere Therapeutics

Columbia (SC)

On-site

USD 132,000 - 172,000

Full time

7 days ago
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Benefits offered by this job

Comprehensive benefits
Competitive compensation
Stock option program

Job summary

Travere Therapeutics is hiring a Senior Manager, Statistical Programming in a hybrid role based in San Diego. Lead programming teams, validate outputs, and oversee CROs to ensure accurate deliverables for clinical development.

The role demands a strong background in SAS, SDTM/ADaM, Define.XML, and regulatory submission experience, with 7+ years in clinical research and leadership capabilities. Travel up to 10% may be required.

Qualifications

  • Bachelor's degree in statistics, CS, mathematics or related field; Master’s preferred.
  • 7+ years in clinical research SAS programming; Lead Programmer experience required.
  • Strong SDTM, ADaM, and Define.XML knowledge; CRO/vendor coordination experience.

Responsibilities

  • Provide programming support across all programs and plan activities.
  • Lead projects, oversee contractors, and ensure timely deliverables.
  • Develop SDTM/ADaM datasets, Define.xml, and supporting documentation.
  • Support SAPs, CRFs, validation plans, and regulatory submissions.

Skills

SAS programming
CDISC specifications
SDTM/ADaM
UNIX
FDA/ICH/GCP knowledge
Vendor management
Regulatory submissions
Leadership

Education

Bachelor's degree in Statistics, Computer Science, Mathematics, or related technical discipline
Master's degree preferred

Tools

SAS
Define.XML
SQL
R

Job description

Travere Therapeutics is hiring a Senior Manager, Statistical Programming in a hybrid role based in San Diego. Lead programming teams, validate outputs, and oversee CROs to ensure accurate deliverables for clinical development.

The role demands a strong background in SAS, SDTM/ADaM, Define.XML, and regulatory submission experience, with 7+ years in clinical research and leadership capabilities. Travel up to 10% may be required.

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