Senior Manager, Statistical Programming

Travere • San Diego, CA

18h • Hybrid

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 programming activities, provides hands-on programming and validation support to project teams, and oversees external vendors to ensure timely and accurate deliverables. It also contributes technical expertise to programming standards and procedures and works cross-functionally.

The position supports clinical development and submission activities, including programming analysis datasets, tables, figures, listings, integrated summaries, safety reports, regulatory documents, electronic submissions, and other internal and external requests. The Senior Manager develops and reviews clinical programming specifications and deliverables, coordinates study programming, and contributes to process improvement and programming standards.

The role is listed as San Diego, USA – Remote, but the posting states that no role is expected to be 100% remote and that positions have an essential function involving face-to-face work with colleagues and/or onsite work in San Diego. 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 clinical research experience, 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.
• 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.
• 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 by taking corrective action and implementing improvements.
• Ability to work independently with minimal supervision, demonstrate initiative and sound judgement, and manage time and organization effectively across multiple projects under tight timelines.
• Ability to travel 10% domestically and internationally.
• Ability to perform face-to-face work with colleagues and/or work onsite in San Diego as an essential job function.

Nice To Haves

• Master’s degree.
• Familiarity or experience with R Software.
• Experience managing vendors and/or direct reports.
• Alignment with Travere’s core values of Courage, Community Spirit, Patient Focus, and Teamwork.

Responsibilities

• Provide strategic input on the development of 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 the quality and timeliness of programming deliverables.
• Program analysis datasets, statistical tables, figures, listings, ISS, ISE, DSUR, PSUR, IB, progress reports, electronic submissions, and other deliverables or requests, including publications and responses to regulatory questions.
• Review and 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 and/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 support the clinical development process.
• Perform additional duties as assigned.

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.
• Short-term incentive compensation.
• Long-term incentive compensation in company stock.

What This Job Offers

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