Key Facts

Remote From:

Freelance

Senior (5-10 years)

English

Hard Skills

SAS (Software) Statistics Health And Safety Standards Clinical Study Design Biostatistics SAP Implementation Protocol Analysis Sample Size Determination Statistical Analysis Digital File Management Statistical Packages Program Development Clinical Study Design Dataset Case Report Forms Data Cleansing

Other Skills

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Verbal Communication Skills
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Team Oriented

Roles & Responsibilities

Master’s degree in statistics or biostatistics
5+ years of experience in biostatistics/clinical trials
SAS programming skills
Knowledge of industry standards and understanding of clinical trial data, preferably for in-vitro diagnostic trials

Requirements:

Conduct project planning activities including protocol and CRF review, sample size calculation, SAP, and Programming Plan (including analysis dataset specifications)
Review project datasets and perform statistical analysis according to the SAP
Incorporate client changes and provide documentation logs for project/study files
Finalize statistical analyses and final CSR components (tables, listings, and figures) and archive all documentation

Beaufort CRO

Research

About Beaufort CRO

Beaufort is a global CRO built around one purpose — helping life science companies improve and save lives through the rapid development and commercialization of innovative products. Our shared interest and commitment to your success drives our entire organization to deliver best-in-class clinical trial services, regulatory strategy and planning, data and business analytics, data management and statistics, and quality services.We are:◈ MedTech Focused - Industry-leading expertise to streamline your clinical development.◈ IVD Specialists - Two decades of extensive diagnostic experience.◈ Results Oriented - Guided by efficient and adaptive clinical trial management. ◈ Partnership Driven - 94% of clients rate Beaufort higher than other CROsOur experience includes:◈ 500+ Regulatory Submissions including 510(k)s, PMAs, IDEs and CE-Marks◈ 4,000+ Clinical Study Sites Around the Globe◈ 1,000+ Clinical Trials Across a Wide Variety of Indications and Testing Platforms◈ 2,600+ Clinical Professionals in Over 50 CountriesSee how Beaufort CRO can accelerate your medical innovation -- and put our experience to work for you.

Company type: SME

Industry: Research

Founded: 2018

Company size: 51 - 200

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Job description

Biostatistician – (Contract)

The Biostatistician will perform statistical duties for one or more particular life science client projects, including clinical trial studies within the in-vitro diagnostic (IVD), medical device and pharmaceutical industry.

Beaufort is a global CRO built around one purpose- helping life science companies improve and save lives through rapid development and commercialization of innovative products.

Key responsibilities include:

Conduct project planning activities such as:

o Protocol and Case Report Form (CRF) Review

o Sample size calculations

o Statistical Analysis Plan (SAP)

o Programming Plan (including analysis dataset specifications)

Review project datasets and perform statistical analysis according to the plan (SAP).

Incorporate client changes or modifications as required and provide documentation logs to include in the project/study files.

Finalizes statistical analysis and final report for inclusion in the Clinical Study Report (CSR) and all appropriate project documentation. This includes tables, listings, and figures. Archive all documentation.

Perform other project-related tasks assigned to the Statistician role as specified in the individual’s Statement of Work.

Qualifications:

Minimum of Master’s degree in statistics or biostatistics
5+ years of experience

Top 3 skills needed to perform the work requested:

Statistics, SAS programming skills, Knowledge of industry standards, Understanding of clinical trial data, preferably clinical trial data for in-vitro diagnostic trials

Non-technical/ personal skills needed:

Effective communication both verbally and written, team player

Beaufort offers a different CRO experience. It’s not just about what we do, it’s how we do it. Together our team brings a level of passion, knowledge and commitment to our projects and clients. We foster a culture of excellence specializing in in-vitro diagnostics, clinical project management, quality oversight and regulatory solutions.

At Beaufort you will be part of industry leading expertise with a shared sense of purpose and unwavering accountability to help clients achieve successful market authorization.

Beaufort is an equal opportunity employer and values diversity.