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 position will work closely with the Senior Director of Statistical Programming and other members of the Biometrics team to provide programming support across all programs. The ideal candidate will provide hands-on programming and validation support to project teams and oversee external vendors to ensure timely and accurate deliverables. This role will provide technical expertise to the development of programming standards and procedures.
Responsibilities:
Program 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).
Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation.
Provide statistical programming and validation support for clinical study reports, oversee external vendors (e.g., CROs), and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
Develop and/or review SAPs, case report forms, clinical DB specifications, validation plans, TLFs, reporting and analysis datasets specifications, and supporting documentation.
Ensure quality of project programming deliverables.
Provide input on programming-related SOPs, work practice documents, technical standards, and programming specification documents.
Provide input on programming methodologies to support the clinical development process.
Education/Experience Requirements:
Bachelor's degree in Statistics, Computer Science, Mathematics, or related technical discipline. Equivalent combination of education and applicable job experience may be considered.
Minimum of 6 years' experience in clinical research, ideally as a SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.
Additional Skills/Experience:
Technical knowledge and experience with SDTM, ADaM, and Define.XML.
Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).
Strong 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 and Windows operating systems.
Submission support with compliance experience.
Understanding of the software development life cycle.
Ability to effectively communicate and perform in a high demand and dynamic working environment.
Strong professional experience in a similar role within the pharmaceutical industry, preferably small molecule pharmaceuticals.
Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
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.
Travere will require proof of vaccination status to perform onsite, face to face work or to become employed.
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:$111,700.00 - $145,000.00
*This information is current as of the initial date of this job posting and may be modified in the future. The actual pay determined for an individual will vary based on job-related factors such as location, relevant prior experience and/or education, particular skills and expertise.
COVID-19 VACCINATION REQUIREMENT
Where permitted, the Company requires all employees to... For full info follow application link.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
