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…