Associate Director, Statistical Programming

Scorpion Therapeutics; California (MO); Hybrid; USD 170,000 - 230,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director, Statistical Programming to support global rare disease programs. The role provides strategic programming input, develops standards, oversees project execution, and ensures compliance for analyses and regulatory submissions.

Responsibilities include leading programming efforts, managing vendors, validating datasets, and preparing SDTM, ADaM, and Define.xml files, with a hybrid work setup in San Diego and limited remote options.

Qualifications

• Bachelor’s degree in statistics, computer science, or a related field.
• 8+ years in clinical research with SAS programming.
• 3–5 years in leadership roles.
• Strong knowledge of CDISC standards, ICH and FDA guidelines, and submission processes.

Responsibilities

• Leading programming efforts for global rare disease programs.
• Managing vendors and overseeing project execution.
• Validating datasets and preparing regulatory deliverables such as SDTM, ADaM, and Define.xml files.

Skills

SAS programming

Leadership

CDISC standards

Regulatory knowledge

Data validation

Education

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

Master's degree

Tools

UNIX

R

Job description

Role: Associate Director, Statistical Programming supporting global rare disease programs within Travere Therapeutics. Main objectives include providing strategic programming input, developing standards, overseeing project execution, and ensuring compliance for clinical trial analyses and submissions.

Responsibilities

• leading programming efforts
• managing vendors
• validating datasets
• preparing regulatory documentation such as SDTM, ADaM, and Define.xml files

Qualifications

• Bachelor's in Statistics, Computer Science, or related field
• at least 8 years' experience in clinical research with SAS programming
• including 3-5 years in leadership roles
• strong knowledge of CDISC standards, regulatory guidelines (ICH, FDA), and submission processes

Preferred

• Master's degree
• experience with UNIX
• R
• vendor management

High-Value

• Supporting phase I-IV trials in rare diseases
• Delivering clinical datasets and reports for regulatory submissions
• with an emphasis on accuracy and efficiency.

Work setup

• Hybrid in San Diego, with face-to-face requirements; remote options limited