Biostatistician II

Responsibilities

• Functions independently as a lead statistician with minimal oversight to deliver the project statistician tasks/responsibilities, including analysis database creation, statistical analyses, and creation of formatted statistical analysis tables and summaries. Provides mentorship to junior team members
• Ensures compliance with the activities outlined in the department's SOPs
• Follows departmental procedures for statistical analyses and programming work
• Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. Ensures that SOPs are being followed and that appropriate project documentation is ongoing
• Interacts with the sponsor on all aspects of the project
• Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for database structures for analysis
• Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis
• Provides randomization schemes and appropriate documentation
• Develops statistical analysis plan, including analysis database and table and listing specifications, and guide others on the team in its implementation
• Programs/validates statistical tables with an emphasis on efficacy endpoints. Provides proper documentation and oversee the work of others who assist in programming/validating
• Reviews reports and other documents and manuscripts. Contributes to the statistical methods section and verify for completeness and consistency for report
• Monitors project budget as it relates to project work scope and communicates proactively with management concerning potential changes in work scope
• Provides general infrastructure support to the department. Examples could include presentation/ teaching at department, contributing to other general department documents or policies, assisting with newsletters, helping in department libraries, or training of new hires

Benefits

• Remote in the United States
• Glassdoor
• 3.5
• Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
• Waltham, Massachusetts, USA
• https://www.thermofisher.com
• Public Company
• Total Funding
• $19.77B
• Key Investors
• National Grid
• 2026-02-09
• Post Ipo Debt· $3.8B
• 2025-11-24
• Post Ipo Debt· $2.42B
• 2025-09-30
• Post Ipo Debt· $2.5B
• Leadership Team
• Marc Casper
• Chairman and CEO
• Daniella Cramp
• Senior Vice President and President, Bioproduction Group
• Recent News
• PR Newswire
• Bioprocess Technology Market to Reach USD 134.06 Billion by 2035 - Credence Research
• 2026-10-17
• Canada NewsWire
• Rockwell Automation and Industry Leaders Launch the Digital CMC Consortium to Accelerate Digital Transformation in Pharmaceutical Development
• 2026-10-08
• BioSpace

Qualifications

• Masters in Biostatistics, Statistics or Math at a minimum is required
• 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
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')
• Project lead client facing experience is required
• Experience programming in SAS and R is required
• Demonstrated initiative and motivation
• Capable of leading complex projects
• Effective management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff
• Strong verbal and written communication skills
• Positive attitude and the ability to proactively direct and promote teamwork in a multi-disciplinary team setting
• Strong knowledge of SAS® and clinical biostatistics
• Strong understanding of the drug development process and FDA regulations
• 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
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).

Required skills

• Clinical Biostatistics, Clinical Trial Design, Drug Development Process, FDA Regulations, R Programming, SAS Programming, Sample Size Calculation, Statistical Analysis, Statistical Analysis Plans

Preferred skills

• Verbal and Written Communication

Experience

• 2+ years