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 - enabling 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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

In Biostatistics and Programming, we are passionate about data and technical agility to drive enhanced value for our customers and patients. Determined to improve patient health, we provide statistics, programming and clinical pharmacology expertise through global delivery, consistent quality adherence and scientific insight. Through a procedural framework based on robust planning and specifications, we deliver clinical trial planning and development programs, results of a study and lead the regulatory submissions.

Discover Impactful Work:

The Senior Biostatistician functions independently as a project lead or lead statistician to deliver theproject tasks/responsibilities. Performs project management functions relating to the administrative and scientific activities of specific project work and team members. Oversees statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians. Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.

A day in the Life:

• Serve as a lead statistician on projects with minor supervision.
• The major responsibility is to support the development and routine operation of vaccine and biologics assays.
• Provide statistical support to experimental design, data analysis, assay validation, scientific research and publication, and assay development.
• Prepare and review reports and protocols.
• Contribute to the statistical methods section and verify for completeness and consistency.
• Create SAS programs, graphs, and tables to perform and interpret analyses.
• Participate in internal meetings. Interact with multiple departments including data management, labs, and IT.
• Analyze Quality Control data to identify trends or anomalies.
• Provide training and support to scientists and other non-statistical professionals.

Keys to Success:

Education

• Master's degree in statistics, biostatistics, mathematics or related field.

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’)
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 

Knowledge, Skills, Abilities

• Strong Microsoft Office skills, including Word, Excel, and PowerPoint.
• SAS programming skills
• R programming skills
• JMP skills
• Ability to promote teamwork in a multi-disciplinary team setting
• Good understanding of basic statistical methodology
• Ability to interact with lab scientists, curious about underlying biology hypothesis, assay technologies, and limitations (both in biology and assay technology).
• Experience with small and simple projects preferred as well
• Ability to ask scientific (rather than just statistical) questions so that the focus is on 'what is the right question' rather than on 'what is a better statistical method for a given question'
• Knowledge of clinical trials structure
• Excellent written and verbal communications skills
• Good organizational skills with the ability to adapt and adjust to changing priorities
• Positive attitude and the ability to work well with others
• Ability to solve problems logically
• Ability to multi-task

Work Environment

Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)