Executive Director, Statistical Programming

Travere•San Diego, CA

1d•Hybrid

About The Position

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 are in rare for life. 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.

Requirements

Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related technical discipline required.
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.
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.
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.

Nice To Haves

Masters preferred.
Equivalent combination of education and applicable job experience may be considered.
Familiarity or experience with R Software is a plus.

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).