Senior Manager, Statistical Programming

Travere Therapeutics • San Diego, CA

1d • $132,000 - $172,000 • Remote

About The Position

The Senior Manager, Statistical Programming works closely with the Associate Director, Statistical Programming, and other Biometrics team members to provide programming support across programs. The role independently plans and coordinates assigned programming activities, provides hands-on programming and validation support to project teams, oversees external vendors to ensure timely and accurate deliverables, contributes technical expertise to programming standards and procedures, and works cross-functionally.

The position supports clinical development analysis, reporting, and submission activities, including programming datasets, tables, figures, listings, integrated summaries, safety reports, electronic submissions, and other internal and external requests. It also contributes to study documentation and programming specifications, applies relevant standards and regulatory requirements, coordinates activities with internal study teams and vendors, and helps improve programming processes and tools.

The position is listed as San Diego, USA—Remote, but the posting states that all positions must be able to perform face-to-face work with colleagues and/or onsite in San Diego and that no role is expected to be 100% remote. Travel of 10% domestically and internationally is required.

Requirements

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related technical discipline; an equivalent combination of education and applicable job experience may be considered.
• At least 7 years of experience in clinical research, ideally as a SAS programmer for Phase I–IV clinical trials in a pharmaceutical or CRO environment.
• Lead Programmer experience.
• Technical knowledge and experience with SDTM, ADaM, and Define.xml.
• Strong understanding of the drug development process, submission-related activities, regulatory requirements such as CDISC, CDASH, and eCTD, and guidelines such as ICH, CHMP, FDA, and GCP.
• Demonstrated experience preparing and validating technical submission programming deliverables in accordance with applicable standards, procedures, and regulatory requirements.
• Thorough knowledge of SAS functionalities, including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS, and experience with MS Office.
• Proven experience with UNIX and Windows operating systems.
• Understanding of the software development life cycle.
• Ability to communicate effectively and perform in a high-demand, dynamic working environment.
• Excellent communication and interpersonal skills.
• Experience solving complex and increasingly difficult problems through corrective action and implementation of improvements.
• Self-motivated, with the ability to manage responsibilities independently with minimal supervision.
• Initiative, sound judgement, flexibility, effective time management and organizational skills, and ability to work on multiple projects simultaneously under tight timelines.
• Ability to travel 10% domestically and internationally.

Nice To Haves

• Master’s degree.
• Experience managing vendors and/or direct reports.
• Familiarity or experience with R Software.
• Alignment with Travere’s core values: Courage, Community Spirit, Patient Focus, and Teamwork; driven, intelligent, and passionate about making a difference for patients with rare diseases.

Responsibilities

• Provide strategic input into statistical programming processes and contribute to maintaining programming-related SOPs, work instructions, and technical standards.
• Assist in developing programming standards and tools to improve the efficiency and accuracy of analysis and reporting for clinical development projects.
• Lead projects and studies, oversee contractors, and ensure programming deliverables are of high quality and completed on time.
• Program analysis datasets, statistical tables, figures, listings, ISS, ISE, DSUR, PSUR, IB, progress reports, electronic submissions, and other internal and external requests, including publications and regulatory responses.
• Review or develop CDISC specifications and review or generate SDTM and ADaM datasets, Define.xml files, and supporting submission documentation.
• Provide statistical programming and validation support for clinical study reports; oversee external vendors such as CROs; and coordinate programming activities with Biometrics leads, data managers, and other study programmers.
• Develop or review SAPs, case report forms, clinical database specifications, validation plans, TLFs, reporting and analysis dataset specifications, and supporting documentation.
• Provide input on applying programming methodologies to the clinical development process.
• Perform additional duties as assigned.
• Travel 10% domestically and internationally.

Benefits

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance.
• Disability benefits.
• Retirement plans with employer match.
• Generous paid time off.
• Base pay and short-term incentive cash compensation.
• Long-term incentive compensation in company stock.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior