Biostatistician II

Thermo Fisher Scientific • Wilmington, NC

5d • Remote

About The Position

Thermo Fisher Scientific is hiring a Biostatistician II to support prospective real-world studies within its clinical research portfolio. The role develops data intelligence and clinical insights to help bring safe and effective treatments to market, with a focus on patient safety and improved health outcomes.

The Biostatistician II functions independently as a lead statistician, with minimal oversight, and delivers project statistician work including analysis database creation, statistical analyses, and formatted statistical tables and summaries. The role leads project teams, works directly with sponsors, coordinates with programmers and data management personnel, and provides mentorship and guidance to junior team members. It also contributes to departmental infrastructure, training, and documentation.

The position is remote within the United States. Applicants must be legally authorized to work in the United States without sponsorship and must pass a comprehensive background check, including drug screening. Relocation assistance is not provided.

Requirements

• Master's degree in Biostatistics, Statistics, or Mathematics at a minimum; an equivalent combination of appropriate education, training, and/or directly related experience may be considered in some cases.
• Comparable experience providing the knowledge, skills, and abilities to perform the job, with 2 or more years of experience.
• Project lead and client-facing experience.
• Experience programming in SAS and R.
• Demonstrated initiative and motivation.
• Ability to lead complex projects.
• Effective management skills, including successful management of multiple projects and staff members, and the ability to mentor and motivate staff.
• Strong verbal and written communication skills.
• Positive attitude and ability to proactively direct and promote teamwork in a multidisciplinary team setting.
• Strong knowledge of SAS and clinical biostatistics.
• Strong understanding of the drug development process and FDA regulations.
• Ability to manage change and uncertainty to optimize positive outcomes.
• Ability to make independent judgments under limited supervision.
• Strong interpersonal skills and a collaborative, team-oriented mindset.
• Legal authorization to work in the United States without sponsorship.
• Ability to pass a comprehensive background check, including drug screening.

Responsibilities

• Deliver project statistician tasks, including creating analysis databases, conducting statistical analyses, and preparing formatted statistical tables and summaries.
• Ensure compliance with departmental SOPs and follow procedures for statistical analyses and programming work.
• Lead project teams, conduct team meetings, maintain timelines, assess and provide resources, prepare budgets, ensure SOP compliance, and maintain project documentation.
• Interact with sponsors on all aspects of projects.
• Coordinate with programmers and data management personnel on database maintenance, updates, and documentation, and provide guidance on analysis database structures.
• Provide sample size calculations and review protocols for completeness, appropriate clinical design, and sound statistical analysis.
• Provide randomization schemes and appropriate documentation.
• Develop statistical analysis plans, including analysis database and table and listing specifications, and guide team members in implementation.
• Program and validate statistical tables, emphasizing efficacy endpoints; document the work and oversee others assisting with programming and validation.
• Review reports, documents, and manuscripts; contribute to statistical methods sections and verify report completeness and consistency.
• Monitor project budgets against work scope and proactively communicate potential scope changes to management.
• Provide general departmental infrastructure support, such as presenting or teaching, contributing to department documents or policies, assisting with newsletters or department libraries, and training new hires.
• Mentor junior team members.

Benefits

• Reasonable accommodation is available for the application or interview process, essential job functions, and other benefits and privileges of employment.

What This Job Offers

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