Executive Director, Biometrics

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:
This leader will serve as the head of the Biostatistics function within the Biometrics department. This position will work closely with the VP of Biometrics in identifying project Biostatistics demands and resource needs. This role will be responsible for leading Biometrics teams, which includes programming and data management, to provide strategic, scientific and statistical leadership to assigned clinical development program(s). This role oversees statistical aspects of assigned projects to ensure that scientific, regulatory, and quality requirements are met and that plans are aligned with development goals. The incumbent will lead and collaborate with cross-functional teams composed of internal and/or external subject matter experts. This role will contribute to the overall efficiency and best practice running of the Biometrics Department. 

Responsibilities:

•    Lead the Biostatistics function and provide strategic input and statistical leadership of multiple clinical studies or projects.
•    Responsible for the planning and delivery of the Biometrics components required to support the design, analysis, and reporting needs of clinical development projects. Work directly with the project teams and external vendors to identify statistical issues, and to propose and implement solutions. 
•    Provide statistical leadership and strategic input to study protocols, study reports, regulatory documents, publications, and other internal or external requests. Perform statistical analyses as needed.
•    Prepare, review and/or approve study protocols, SAPs, case report forms, clinical DB specifications, validation plans, TLFs, reporting and analysis datasets specifications, and supporting documentation.
•    Provide oversight to internal and/or external Biometrics teams to ensure timeliness and quality of deliverables. 
•    Lead or contribute to the development and maintenance of Biometrics-related SOPs, work practice documents, technical standards, and specification documents. 
•    Research and apply new statistical approaches as needed. Initiate and drive innovation by implementing relevant innovative designs or analyses in support of program strategy. Develop new or leverage existing statistical methodologies to convert data into information to enable decision making. 
•    Manage biostatisticians and contribute to the professional development of Biometrics personnel by conducting trainings or coaching.
•    Lead or contribute to process improvements within Biometrics.

Education/Experience Requirements:

•    M.S. in Statistics/Biostatistics is required, Ph.D. is preferred.  
•    12+ years of relevant experience in the biopharmaceutical industry.
•    Hands-on experience in all tasks of a Lead Statistician (at least 10 years), including late-stage drug development, regulatory submissions, and Health Authority interactions. Experience with disease registries is a plus.

Additional Skills/Experience/Requirements:

•    NDA or MAA experience is a must.
•    Extensive vendor and personnel management experience.
•    Broad and thorough understanding of the drug development process, from early to late stage.
•    Experience in orphan or rare diseases is preferred.
•    Broad and thorough understanding of statistical principles and clinical trial methodology.
•    Broad and thorough understanding of FDA and ICH requirements and industry standards applicable to the design, conduct and analysis of clinical trials, including SDTM, ADaM, and CDISC/eCTD requirements for regulatory