Remote Senior Lead, Statistical Programming

Travere Therapeutics; Washington (District of Columbia); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health insurance

Well-being programs

Paid time off

Life insurance

Disability insurance

Retirement match

Job summary

Travere Therapeutics is seeking an Associate Director of Statistical Programming in San Diego, remotely located as needed, to provide hands-on programming support across programs and supervise external vendors ensuring timely, accurate deliverables. The role partners with the Biometrics team, develops programming standards, and drives regulatory submissions.

Ideal candidates have 8+ years in clinical research, SAS expertise, and leadership experience in a CRO/pharma setting, with SDTM/ADaM/CDISC

Qualifications

• Bachelor's degree in Statistics, Computer Science, Mathematics, or related field
• Minimum 8 years' experience in clinical research, SAS programming for phase I-IV trials
• 3-5 years of progressive leadership with at least 3 years as Lead Programmer

Responsibilities

• Provides strategic input regarding the development of statistical programming processes and contribute to maintaining programming-related SOPs, work instructions, and technical standards.
• Assists in the development of programming standards and tools to improve the efficiency and accuracy required to support the analysis and reporting for clinical development projects.
• Lead projects/studies, oversee contractors, and ensure quality and timeliness of programming deliverables.
• Program analysis datasets, statistical tables, figures, listings, and regulatory submissions and other requests.
• Reviews/Develops CDISC specifications and review/generate SDTM/ADaM datasets and Define.xml files.
• Provides programming and validation support for clinical study reports, oversee external vendors, and coordinate activities with Biometrics lead and data managers.
• Develops and/or reviews SAPs, CRFs, clinical DB specs, validation plans, TLFs and reporting datasets.
• Provides input on applying programming methodologies to support the clinical development process.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Vendor management

Cross-functional collaboration

Education

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

Tools

UNIX

Windows

MS Office

R (basic)

Job description

Travere Therapeutics is seeking an Associate Director of Statistical Programming in San Diego, remotely located as needed, to provide hands-on programming support across programs and supervise external vendors ensuring timely, accurate deliverables. The role partners with the Biometrics team, develops programming standards, and drives regulatory submissions.

Ideal candidates have 8+ years in clinical research, SAS expertise, and leadership experience in a CRO/pharma setting, with SDTM/ADaM/CDISC