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Fortrea · 1 day ago

Principal Biostatistician - FSP

United States

Full-time

Remote

Senior Level, Lead/Staff

$130K/yr - $150K/yr

10+ years exp

Fortrea is a respected global company in the pharmaceutical and biotech industry, seeking a Principal Biostatistician for their Flexible Solutions business unit. The role involves leading complex clinical trials, developing statistical analysis plans, and mentoring junior staff.

Clinical TrialsHealth Care

No H1B

Hiring Manager

Lindsay Lonneberg

Responsibilities

Lead complex studies such as New Drug Applications 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 Data Monitoring Committee 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

Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery

Review Case Report Form and other study specific specifications and plans

Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant

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

Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives

Represent the department during audits

Qualification

SAS programmingStatistical Analysis PlansLead Biostatistician experienceSDTMsADaM datasetsClinical trial process knowledgeBusiness fluency in EnglishCommunication skillsOrganizational skillsAttention to detailTeam collaboration

Required

Degree in a relevant field such as statistics, biostatistics, public health, etc

Solid experience (10+ years) of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company

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 professional experience with SDTMs, ADaM datasets and TFLs

Proven ability to effectively communicate statistical concepts

A good knowledge of the overall clinical trial process

Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials

Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail

Business fluency in English – both verbal and written – is a must