Biostatistician II

Thermo Fisher Scientific • Wilmington, NC

8d • Onsite

About The Position

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. As part of our clinical research portfolio, our CorEvitas evidence-based solutions specialize in generating data intelligence and clinical insights needed to bring safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on – now and in the future.

Requirements

• Master's degree in statistics, biostatistics, mathematics is required.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• SAS and CDISC are required.
• CRO, pharma or closely related industry clinical trial experience is required.
• Project lead experience is required.
• Solid SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures
• Solid understanding of statistical principles and good statistical skills
• Capable of creating study specifications and providing support in the review of data management documentation
• Good project management skills as shown through management of multiple projects
• Solid written and verbal communications skills, including proficiency in the English language
• Good organizational skills with the ability to adapt and adjust to changing priorities
• Positive attitude and the ability to work well with others

Nice To Haves

• R programming is preferred.

Responsibilities

• Ensures compliance with the activities outlined in the department's SOPs.
• Follows departmental procedures for statistical analyses and programming work.
• Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget.
• Ensures that SOPs are being followed and that appropriate project documentation is ongoing.
• Interacts with the sponsor on all aspects of the project.
• Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for database structures for analysis.
• Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis.
• Provides randomization schemes and appropriate documentation.
• Develops statistical analysis plan, including analysis database and table and

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level