Principal Biostatistician FSP

Fortrea•Durham, CA

5d•Hybrid

About The Position

This role involves leading complex studies, such as NDA submissions or intricate, multi-protocol programs. The Principal Biostatistician will provide statistical oversight, coordinate activities across multiple locations, and manage project timelines and resources. A key responsibility includes serving as a DMC Support Statistician, developing Charters, and attending DMC Meetings under the guidance of Statistical Consultants. The position also requires leading the development of complex Statistical Analysis Plans, performing senior reviews of analyses, conducting complex statistical analyses, and quality checking work done by other statisticians. A thorough review of tables, listings, and figures (TFLs) for complex studies before client delivery is expected. The role also involves reviewing CRF and other study-specific specifications, performing complex sample size calculations under supervision, and developing statistical sections of protocols for complex studies. Input and review of Clinical Study Reports (CSRs) for complex studies, and preparation/review of randomization specifications and schedules are also part of the duties. Additionally, the role includes mentoring and training junior staff, representing the department during audits, and attending bid defense meetings for complex studies to secure new business. Subject Matter Expert duties, procedural document development, and participation in new initiatives are also expected.

Requirements

Bachelor’s degree. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
8+ years of experience or an equivalent combination of education or experience to successfully perform the key responsibilities of the job.
Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses.
SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data, and survival analysis.
Proven ability to effectively communicate statistical concepts.
A good knowledge of the overall clinical trial process and of its application within Fortrea Clinical Development.
Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials.

Nice To Haves

Master’s degree, equivalent, or higher in Biostatistics or related field.

Responsibilities

Lead complex studies such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight, and attending relevant project meetings.
Perform project management activities for identified projects including resource planning, timelines, and milestone management.
Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants.
Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians.
Perform complex statistical analyses, quality check statistical analyses developed by other statisticians.
Conduct overall statistical review of TFLs for complex studies prior to client delivery.
Review CRF and other study specific specifications and plans.
Perform complex sample size calculations under the supervision of more senior statistical staff.
Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant.
Provide statistic input and review of the CSR for complex studies.
Preparation and review of randomization specifications and generation of randomization schedules.
Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures.
Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences.
Attend bid defense meetings for complex studies such as NDA submissions or complex, multiprotocol programs in order to win new business.
Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives.
Represent the department during audits.
All other duties as needed or assigned.