Sr Biostatistician II

Thermo Fisher Scientific • Wilmington, NC

1d • Remote

About The Position

Thermo Fisher Scientific is seeking a senior biostatistician to independently lead statistical work on clinical research projects, with minimal oversight. The role includes delivering project statistician responsibilities such as creating analysis databases, conducting statistical analyses, and preparing formatted statistical analysis tables and summaries. The position also provides senior project review and mentorship to junior colleagues.

The Sr Biostatistician II leads teams across complex projects, works with sponsors and regulatory agencies, and contributes to study design, protocols, analysis plans, database development, reporting, budgeting, and business development. The role follows departmental procedures and standard operating procedures while identifying opportunities for process improvement. This is a remote position in the United States. The successful candidate must be legally authorized to work in the U.S. without sponsorship and 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 directly related experience may be considered in some cases.
• At least 4 years of comparable experience providing the knowledge, skills, and abilities to perform the job.
• Project lead and client-facing experience.
• Experience programming in SAS and R.
• Comprehensive SAS programming skills, including BASE, STAT, MACRO, and GRAPH.
• Ability to direct and promote teamwork in a multidisciplinary team setting.
• Ability to review current processes and identify potential improvements.
• Comprehensive understanding of a wide variety of clinical trials and designs and the corresponding reporting of data.
• In-depth understanding of interpreting results from statistical analyses of complex data.
• Strong project management skills, including management of multiple projects.
• Demonstrated initiative and motivation.
• Excellent written and verbal communication skills, including proficiency in English.
• Strong organizational, time management, and planning skills, including the ability to create and follow timelines, plan long range, adapt to changing priorities, and handle multiple projects.
• Strong interpersonal skills and a positive attitude to work effectively in a team and liaise with other departments.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, including drug screening.

Responsibilities

• Ensure compliance with departmental standard operating procedures and contribute to changes as needed.
• Follow departmental procedures for statistical analyses and programming work.
• Independently lead statistical work on challenging projects, provide senior project review, and lead team members across multiple complex projects.
• Interact with sponsors on all aspects of projects and present to sponsors and regulatory agencies as needed.
• Review sample size calculations and protocols for completeness, appropriate clinical design, and sound statistical analysis; contribute to protocol sections.
• Review randomization-related documentation.
• Write and review analysis plans, guide team members in implementation, and define appropriate statistical analysis methods and procedures.
• Review statistical analyses for key efficacy endpoints.
• Review analysis database specifications, oversee database development, and ensure completeness for programming; coordinate with programmers and data management on database maintenance, updates, and documentation.
• Supervise creation of table and listing specifications.
• Prepare reports, manuscripts, and other documents; contribute statistical methods sections for integrated clinical and statistical reports, integrated summaries of safety and efficacy, and other documents.
• Monitor project budgets against work scope and proactively communicate potential scope changes to management.
• Communicate with sponsors about project scope and budget changes after reviewing them with management.
• Mentor department members through project guidance, statistical advice, employee development, performance planning, and resource planning.
• Provide input on hiring recommendations, department policies, and resourcing requirements.
• Represent the department to other divisions.
• Assist with bidding and business development activities and consult with business development on bids and timelines.

What This Job Offers

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