Biostatistician Jobs

About The Position

Requirements

• Master's degree in Statistics, Biostatistics, or a related field is required; 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 and solution-focused, with the ability 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.
• Embodies Travere’s core values of Courage, Community Spirit, Patient Focus, and Teamwork; is 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 offerings for eligible employees and dependents.
• Financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance.
• Disability coverage.
• Retirement plans with employer match.
• Generous paid time off.
• Short-term incentive compensation.
• Long-term incentive compensation in the form of company stock.