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Biostatistician II

ThermoFisher Scientific • Waltham, MA • 11h ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

When you're part of the team at Thermo Fisher Scientific, you'll do important work. And you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division-Specific Information:

This position is based in Massachusetts. Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check, which includes a drug screen.

Schedule: 8 a.m.-5 p.m. M-F

Discover Impactful Work:

As a Statistician on our collaborative Biostatistics team, you will play a key role in shaping the future of diagnostic innovation . Your analyses will help guide product development across IVD assays, instruments, and software. You'll partner closely with R&D, Clinical Affairs, Regulatory Affairs, and Operations to design and analyze studies that directly support regulatory submissions and improve patient outcomes.

A Day in the Life:

Write and review statistical analysis plans for analytical and clinical validation studies.

Apply DOE principles, conduct statistical analyses, and clearly communicate interpretations.

Calculate clinical accuracy metrics (PPA, NPA, PPV, NPV) and deliver analyses to support regulatory filings.

Generate tables, listings, and figures aligned with study protocols.

Review and QC statistical outputs from peers, ensuring scientific integrity.

Write and validate SAS code and macros to support standardized workflows.

Collaborate in cross-functional study teams, contributing data-driven insights that influence key decisions.

Partner with colleagues across functions to advance innovative diagnostics .

Keys to Success:

Education

MS in Statistics or Biostatistics is required.

SAS programming certification is a plus.

Experience

1+ years of experience as a statistician in IVD, medical devices, pharmaceutical, or life sciences settings (equivalent combinations of education and relevant work experience may be considered).

Proficiency in SAS and SAS Macros; experience with R and SQL is preferred.

Experience analyzing complex data from multiple sources and familiarity with CLSI standards.

Knowledge of Next-Generation Sequencing (NGS) is a plus.

Knowledge, Skills & Abilities

Solid understanding of statistical theory, experimental design, and clinical trial methodologies.

Proficiency with linear and non-linear modeling, mixed models, categorical and nonparametric methods, bootstrapping, multiple imputations, and sample size calculations.

Ability to manage multiple projects in a fast-paced environment.

Skill in translating scientific questions into practical, data-analytic solutions.

Excellent written and verbal communication skills - able to simplify complex ideas and build strong partnerships.

Flexibility to work across multiple time zones when needed.

Benefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $75,900.00-$113,850.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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