Senior Manager, Statistical Programming – Remote (SAS/CDISC)

Travere Therapeutics; United States; On-site; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health

Financial benefits

Work-life and well-being programs

Life insurance

Disability insurance

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics, based in San Diego, is seeking an experienced Senior Manager, Statistical Programming to support all programs within Biometrics. You will independently plan, execute, and validate programming activities, while coordinating with external vendors to ensure timely, accurate deliverables.

The role requires leadership in SDTM/ADaM, Define.XML, and regulatory submission support, with 7+ years in clinical research and a strong SAS skill set.

Qualifications

• Bachelor's degree in Statistics, Computer Science, Mathematics, or a related technical discipline required.
• 7+ years' experience in clinical research required, ideally as a SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
• Lead Programmer experience is required.
• Technical knowledge and experience with SDTM, ADaM, and Define.XML.

Responsibilities

• Provide strategic input regarding the development of statistical programming processes and contribute to maintaining programming-related SOPs, work instructions, and technical standards.
• Assist 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, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests.

Skills

SAS

SAS programming

UNIX

Windows

CDISC

SDTM

ADaM

Define.XML

Regulatory knowledge

Vendor management

Education

Bachelor's degree in Statistics or related

Master's degree preferred

Tools

R Software

MS Office

SAS

Job description

Travere Therapeutics, based in San Diego, is seeking an experienced Senior Manager, Statistical Programming to support all programs within Biometrics. You will independently plan, execute, and validate programming activities, while coordinating with external vendors to ensure timely, accurate deliverables.

The role requires leadership in SDTM/ADaM, Define.XML, and regulatory submission support, with 7+ years in clinical research and a strong SAS skill set.