Key Facts

Remote From:

Fixed term

Senior (5-10 years)

English

Hard Skills

Standards Organization SAS (Software) Dataset Statistical Analysis Protocol Analysis Statistical Analysis Digital File Management Regulatory Compliance Project Management Program Development Clinical Study Design Dataset Case Report Forms Collaborative Design

Other Skills

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Quality Control
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Verbal Communication Skills

Roles & Responsibilities

Minimum Bachelor's degree
5+ years of experience
SAS programming skills
Knowledge of industry standards and understanding of clinical trial data (preferably IVD trials)

Requirements:

Review pre-project and planning activities including Protocol and CRF Review, Statistical Analysis Plan Review, and Programming Plan (including analysis dataset specifications)
Create the analysis dataset and perform statistical analysis according to the plan; validate the statistical analysis; incorporate client changes and maintain documentation logs
Finalize statistical analysis and provide the final report for inclusion in the CSR and all project documentation, including tables, listings, and figures; archive all documentation
Perform other project-related tasks as specified in the individual’s Statement of Work

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

Statistical Programmer -Contract

Beaufort CRO seeks an experienced Statistical Programmer for contract based work.

The Statistical Programmer’s duties include SAAS programming and analysis 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:

· Review of pre-project and planning activities such as: Protocol and Case Report Form (CRF) Review, Statistical Analysis Plan Review, Programming Plan (including analysis dataset specifications)

· Once the plan is approved and output finalized, Statistical Programmer creates the analysis dataset and performs statistical analysis according to the plan. Validates the statistical analysis according to the plan. Incorporates client changes or modifications as required. Provides documentation logs to include in the project/study files.

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

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

Qualifications:

Minimum Bachelor’s degree.
5+ years of experience

Top 3 skills needed to perform the work requested:

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 verbal and written
Collaborative work style

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.