Senior Biostatistician

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 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 Senior Biostatistician will work closely with the Biometrics Team lead to provide statistical support for assigned clinical studies. This role contributes to study design, statistical analysis, reporting, and interpretation of clinical trial data under the guidance of more senior statisticians. The incumbent will provide hands-on statistical support and work closely with statistical programming, data management, clinical development, and external vendors to support the timely and high-quality delivery of study-level Biometrics deliverables.

The Senior Biostatistician will collaborate with cross-functional study teams and apply established statistical methods and regulatory standards to support clinical development activities.

Responsibilities:

• Provide statistical support for assigned clinical studies under the guidance of the Biometrics/Biostatistics Team Lead or other senior statistical leadership.
• Collaborate with clinical, data management, statistical programming, and other cross-functional team members to support study activities.
• Contribute statistical input to study design, protocol development, endpoint definition, and analysis planning.
• Prepare and review assigned statistical analysis plans, case report forms, clinical database specifications, validation plans, table, figure, and listing shells, analysis dataset specifications, and related documentation.
• Perform statistical analyses, simulations, and ad hoc analyses as needed.
• Review statistical outputs and supporting documentation for accuracy, consistency, and compliance with study requirements.
• Work with statistical programming and data management to support the timely delivery of study-level datasets, analyses, and reports.
• Review assigned statistical deliverables prepared by external vendors or contract research organizations and escalate issues to the study lead as appropriate.
• Contribute statistical input to clinical study reports, regulatory documents, publications, presentations, and internal data requests.
• Identify and evaluate complex statistical or data-related issues within assigned work and propose solutions in consultation with senior statisticians.
• Apply established statistical methodologies to clinical trial data to support interpretation and decision-making.
• Contribute to Biometrics standard operating procedures, work practice documents, templates, and technical standards.
• Additional duties assigned as need.

Education/Experience Requirements:

• Master's degree in Statistics, Biostatistics, or related field is required; a Ph.D. is preferred. An equivalent combination of education and applicable job experience may be considered.
• 2+ years of relevant statistical experience in the biopharmaceutical industry, contract research organization, or a related clinical research environment is required.

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.
• Hands-on experience supporting statistical activities for clinical studies.
• Knowledge of statistical principles and methods applicable to the design, conduct, analysis, and reporting of clinical trials.
• Experience with study designs, power and sample-size calculations, longitudinal data analysis, survival analysis, statistical modeling, or simulations.
• Working knowledge of FDA and ICH requirements and applicable industry standards for clinical trial analysis and reporting.
• Familiarity with CDISC standards, including SDTM and ADaM.
• Proficiency in SAS programming for statistical analyses and the production or review of tables, listings, and figures.
• Experience with R or other statistical software is preferred.
• Familiarity with clinical trial documents and deliverables, including protocols, statistical analysis plans, clinical study reports, and analysis dataset specifications.
• Experience working with external vendors or contract research organizations is preferred.
• General knowledge of the drug development process.
• Self-motivated and can independently manage responsibilities and meet timelines with minimal supervision.
• Strong communication and collaboration skills.
• Ability to explain statistical concepts clearly to non-statisticians.
• Detail-oriented, solution-focused, and able to work effectively in a dynamic environment.
• Ability to travel as needed, up to 10%.
• All positions have an essential job function requiring the ability to perform face-to-face work with colleagues 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: $116,000.00 - $151,000.00 *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.

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 [email protected]. 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.