Biostatistician II

Thermo Fisher Scientific

. Function independently as a lead statistician with minimal oversight .

Posted 10/20/2026full-timeRemote • North Carolina • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in statistical analysis and biostatistics, with a strong foundation in SAS and R programming. Proven ability to lead projects, mentor teams, and ensure compliance with FDA regulations and departmental SOPs.

Highest-signal resume keywords

Masters In BiostatisticsSAS ProgrammingR ProgrammingClinical BiostatisticsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisDatabase CreationSample Size CalculationsRandomization SchemesStatistical Analysis PlansProgramming ValidationEfficacy EndpointsStatistical MethodsDocumentation ReviewBudget Management

Soft Skills

MentorshipEffective CommunicationTeamworkInitiativeChange Management

Industry Keywords

Drug Development ProcessFDA RegulationsSOP ComplianceClient Facing ExperienceMulti-Disciplinary Team

About the role

Key responsibilities & impact

Function independently as a lead statistician with minimal oversight
Deliver project statistician tasks and responsibilities, including analysis database creation, statistical analyses, and formatted statistical analysis tables and summaries
Provide mentorship to junior team members
Ensure compliance with departmental SOPs and procedures
Lead project teams, conduct meetings, maintain timelines, assess resources, prepare budgets, 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
Guide database structures for analysis
Provide sample size calculations and review protocols for clinical design and statistical analysis
Provide randomization schemes and documentation
Develop statistical analysis plans, analysis databases, and table/listing specifications
Guide team members in implementing statistical analysis plans
Program and validate statistical tables, emphasizing efficacy endpoints
Document and oversee programming and validation work
Review reports, documents, and manuscripts
Contribute to statistical methods sections and verify report completeness and consistency
Monitor project budgets against work scope and communicate potential scope changes to management
Provide department infrastructure support, including presentations, teaching, policy/document contributions, newsletters, department libraries, and new-hire training

Requirements

What you’ll need

Masters in Biostatistics, Statistics or Math at a minimum is required
An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient
Previous experience comparable to 2+ years
Project lead client facing experience is required
Experience programming in SAS and R is required
Strong knowledge of SAS® and clinical biostatistics
Strong understanding of the drug development process and FDA regulations
Demonstrated initiative and motivation
Capable of leading complex projects
Effective management skills, including successful management of multiple projects and staff members
Proven ability to mentor and motivate staff
Strong verbal and written communication skills
Ability to proactively direct and promote teamwork in a multi-disciplinary team setting
Capable of managing change and uncertainty to optimize positive outcomes
Ability to make independent judgments under limited supervision
Strong interpersonal skills and a collaborative team-oriented mindset
Must be legally authorized to work in the US without sponsorship
Must be able to pass a comprehensive background check, including a drug screening

Benefits

Comp & perks

Relocation assistance is NOT provided
Reasonable accommodation for individuals with disabilities during the application, interview, and employment process
Accessibility service for job seekers requiring accommodations in the application process