Biostatistician II

Thermo Fisher Scientific•Wilmington, NC

3d•Remote

About The Position

Thermo Fisher Scientific is hiring a Biostatistician II to lead statistical work for clinical research and prospective real-world studies. The role independently delivers project statistician responsibilities with minimal oversight, including analysis database creation, statistical analyses, and formatted statistical tables and summaries. The Biostatistician II leads project teams, mentors junior colleagues, and interacts with sponsors on project matters. The position is remote in the United States, and relocation assistance is not provided. Applicants must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening.

Requirements

Master's degree in Biostatistics, Statistics, or Math at a minimum; in some cases, an equivalent combination of appropriate education, training, and directly related experience may qualify.
At least 2 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.
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 setting.
Strong knowledge of SAS and clinical biostatistics.
Strong understanding of drug development and FDA regulations.
Ability to manage change and uncertainty to optimize outcomes.
Ability to make independent judgments under limited supervision.
Strong interpersonal skills and a collaborative, team-oriented mindset.
Legally authorized to work in the United States without sponsorship.
Ability to pass a comprehensive background check, including drug screening.

Responsibilities

Independently lead statistical project work, including analysis database creation, statistical analyses, and formatted statistical tables and summaries.
Mentor junior team members.
Ensure compliance with departmental SOPs and follow procedures for statistical analyses and programming.
Lead project teams, conduct meetings, maintain timelines, assess and provide resources, and prepare budgets.
Ensure SOPs are followed and project documentation is maintained.
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.
Calculate sample sizes 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 their 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 the statistical methods section and verify report completeness and consistency.
Monitor project budgets against scope and proactively communicate potential scope changes to management.
Provide departmental infrastructure support, such as teaching or presentations, contributing to department documents or policies, assisting with newsletters or libraries, and training new hires.