Executive Director, Statistical Programming

Travere Therapeutics; San Diego (CA); On-site; USD 246,000 - 332,000; Full time

Benefits offered by this job

Premium health insurance

Generous paid time off

Retirement plans with employer match

Job summary

Travere Therapeutics in San Diego is seeking an Executive Director, Statistical Programming to lead their Biometrics Department. The role involves ensuring the quality of programming deliverables for all clinical trials and providing hands-on support to teams. Candidates should have 14+ years of SAS programming experience, with 7 years in a leadership capacity.

This position includes a competitive salary range of $246,000 - $332,000 and allows for some remote work, but face-to-face interaction is essential. The company values patient focus and teamwork in contributing to their mission for rare diseases.

Qualifications

• 14+ years of experience in clinical SAS programming for phase I-IV trials.
• At least 7 years in a leadership role within a pharmaceutical/CRO environment.
• Strong understanding of submission-related activities and regulatory requirements.

Responsibilities

• Lead the Statistical Programming function within the Biometrics Department.
• Ensure quality of programming deliverables for clinical projects.
• Manage programming activities and contribute to the professional development of personnel.

Skills

Leadership in statistical programming

SAS programming expertise

Clinical development knowledge

Vendor management

Education

Bachelor's degree in Statistics, Computer Science, Mathematics

Master's degree preferred

Tools

SAS

MS Office

R Software

Job description

Department: 106300 Biometrics

Location: San Diego, USA - Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast‑paced environment and share in our mission – to identify, develop and deliver life‑changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

Position Summary

The Executive Director, Statistical Programming will lead the Statistical Programming function within the Biometrics Department and will work closely with the head of Biometrics in identifying project programming demands and resource needs. The ideal candidate will provide hands‑on support to project teams by carrying out and conducting programming activities, leading statistical programmers, and coordinating with external vendors, statisticians, and other business functions to ensure timely and accurate programming and validation activities for clinical studies. This role will contribute to the overall efficiency and best practice running of the Biometrics Department, demonstrating the ability to work efficiently and to a high standard within a cross‑functional team environment. Strong technical skills and experience supporting submissions are required.

Responsibilities

• Serve as head of the Statistical Programming function within the Biometrics Department.
• Provide strategic input and leadership to the delivery of statistical programming contributions across all clinical development projects.
• Overall accountability of programming deliverables required to support the analysis and reporting for clinical development projects.
• Provide statistical programming and validation support for clinical study reports and coordinating programming activities among the study programmers to achieve timely progress in the following areas: 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 (e.g., publications, responses to regulatory questions).
• Lead and contribute to the development and review of case report forms, clinical DB specifications, SAP, reporting and analysis datasets specifications, validation plans, and TLFs.
• Ensure quality of all project programming deliverables.
• Lead the development and maintenance of programming‑related SOPs, work practice documents, technical standards, and programming specification documents.
• Ensure that Biometrics systems and processes are up to date in terms of scalability, connectivity, and security, in collaboration with IT and QA.
• Manage or provide oversight to third party service providers (i.e., contractors or CROs). Conduct vendor qualifications and GCP audits (in collaboration with QA), as appropriate.
• Identify and lead the application of programming methodologies to support all aspects of the clinical development process. Leverage programming tools to convert data into information to enable decision making. Identify the need for and lead the development and maintenance of applications used for analysis and reporting.
• Manage programmers and contribute to the professional development of Biometrics personnel by conducting trainings and coaching.
• May represent the Biometrics Department in cross‑departmental initiatives and projects (e.g., process and quality improvements).

Education & Experience Requirements

• Bachelor's degree in Statistics, Computer Science, Mathematics, or a related technical discipline required. Masters preferred. Equivalent combination of education and applicable job experience may be considered.
• 14+ years of experience in clinical SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment, with at least 7 years in a leadership or management role.

Additional Skills & Experience

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Strong managerial / technical understanding of programming and clinical related issues along with an ability to demonstrate significant leadership of SAS programming technical activities in a clinical pharmaceutical/CRO environment.
• Extensive experience in managing vendors and direct reports.
• Extensive technical knowledge and experience with SDTM, ADaM, and Define.XML.
• Strong understanding of the drug development process, submission‑related activities and regulatory requirements (e.g., CDISC, CDASH, eCTD) and guidelines (e.g., ICH, CHMP, FDA, GCP).
• Submission support with compliance experience.
• Advanced knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office are required. Familiarity or experience with R Software is a plus.
• Proven experience with UNIX or Windows operating systems.
• Strong understanding of the software development and maintenance life cycle.
• Ability to effectively communicate and perform in a high demand and dynamic working environment.
• Ability to travel 10% domestically and internationally.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Benefits

Our benefits include premium health, financial, work‑life and well‑being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.

Compensation

Our competitive compensation package includes a combination of both cash compensation (base pay and short‑term incentive) and long‑term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range

$246,000.00 - $332,000.00

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.