Department:
106300 Biometrics

Location:
San Diego, USA- Remote

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.

Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.

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

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Travere will accept applications on an ongoing basis until a candidate is selected for the position.