Remote Director Statistical Programming Jobs in California

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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 individual will be responsible for the design, leadership, and implementation of Modeling & Simulation strategies across Travere clinical programs. In this role, you will perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches. You will set the strategy for addressing pharmacometric issues and directly influences drug development decisions. The successful candidate will have good quantitative pharmacology skills, scientific reasoning, exploratory graphical analysis skills and report writing skills.

Responsibilities:

• Developing and executing modeling and simulation strategies from the early through late-stage clinical development and serve as the SME in cross-functional development program teams

• Delivering strategic and well-timed modeling input at key decision points along the development path

• Set the strategy for addressing pharmacometric issues in regulatory submissions and directly influences drug development decisions

• Lead and drive PMX contributions to integrate relevant technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies

• Use state of the art modeling and simulation approaches to interpret PK/PD data and accountable and responsible for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, and exposure-response analysis

• Guide empirical modeling/QSP approaches to understand relationship between PK, biomarkers and disease outcomes undefined

Education/Experience Requirements:

• PhD or PharmD in Pharmaceutical sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent) required

• 4+ years experience of relevant industry experience required including experience in NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation

• Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas

• Experience with incorporation of MIDD strategies into drug development across all phases and responding to questions on dose and regimen justification, study design among others

• Hands-on experience with at least NONMEM and R is strongly preferred.

Additional Skills/Experience/Requirements:

• The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.

• Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a small, fast-moving and entrepreneurial environment.

• Ability to manage multiple, complex tasks with competing timelines.

• Strong interpersonal, verbal, and written communication skills.

• Driven, intelligent, passionate about making a difference for patients with rare diseases.

• Self-motivated and can independently manage responsibilities.

• 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.

• Ability to travel (<10%).

#LI-Remote

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

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:

*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.

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

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.