Senior Biostatistician

Travere Therapeutics•San Diego, CA
•$116,000 - $151,000•Remote

About The Position

The Senior Biostatistician provides statistical support for assigned clinical studies in collaboration with the Biometrics Team lead and under the guidance of more senior statisticians. The role contributes to study design, statistical analysis, reporting, and interpretation of clinical trial data, and provides hands-on support for the timely, high-quality delivery of study-level Biometrics deliverables. The position collaborates with cross-functional study teams and applies established statistical methods and regulatory standards to support clinical development activities. The role works closely with statistical programming, data management, clinical development, and external vendors. It contributes to study documentation and deliverables, supports the review and interpretation of clinical trial outputs, and helps resolve statistical or data-related issues. The position is listed as remote in San Diego, but all positions require the ability to perform face-to-face work with colleagues or onsite in San Diego; no role is expected to be 100% remote. Travel may be required up to 10%.

Requirements

  • Master's degree in Statistics, Biostatistics, or a related field; an equivalent combination of education and applicable job experience may be considered.
  • At least 2 years of relevant statistical experience in the biopharmaceutical industry, a contract research organization, or a related clinical research environment.
  • 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.
  • 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.
  • Familiarity with clinical trial documents and deliverables, including protocols, statistical analysis plans, clinical study reports, and analysis dataset specifications.
  • General knowledge of the drug development process.
  • Ability to independently manage responsibilities and meet timelines with minimal supervision.
  • Strong communication and collaboration skills, including the 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%.
  • Ability to perform face-to-face work with colleagues or onsite in San Diego.

Nice To Haves

  • Ph.D. in Statistics, Biostatistics, or a related field.
  • Experience with study designs, power and sample-size calculations, longitudinal data analysis, survival analysis, statistical modeling, or simulations.
  • Experience with R or other statistical software.
  • Experience working with external vendors or contract research organizations.
  • Embody Travere’s core values: Courage, Community Spirit, Patient Focus, and Teamwork.
  • Driven, intelligent, and passionate about making a difference for patients with rare diseases.

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 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.
  • Perform additional duties as assigned.

Benefits

  • Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
  • Wellness and employee support programs.
  • Life insurance and disability coverage.
  • Retirement plans with employer match.
  • Generous paid time off.
  • Cash compensation consisting of base pay and a short-term incentive.
  • Long-term incentive compensation in the form of company stock.
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