Lead Biostatistician - FSP at Thermo Fisher Scientific

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Master or doctorate (Ph.D.) degree in Statistics or related field with a minimum of 5 years experience (which may include doctoral research in field of biostatistics)
Expertise in drug development, with a demonstrated track record of advanced knowledge of biostatistics and strong command of its application to clinical trials
Extensive study design and sponsor experience required
Candidates must be East-coast based in the United States with flexibility to travel
Proficient in statistical software (SAS and/or R)
Ability to collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials
Ability to clearly explain complex statistical concepts in written and spoken English
Team-player with focused attitude
Able to work autonomously as part of a cross-disciplinary team in a dynamic surrounding of a fast growing biotech company with challenging timelines
Physical ability to work in an office environment: stationary for 6-8 hours per day, repetitive hand movements, frequent mobility, occasional crouching/stooping/bending/twisting, light to moderate lifting (up to 15-20 lbs), occasional domestic and international travel

Responsibilities

Contribute statistical expertise to the design and analysis of one or more clinical trials or the clinical development plan of one compound/program
Closely collaborate with program partners and stakeholders to deliver on the statistical deliverables for one or more clinical trials and contribute to HA submissions
Report to a franchise team leader, within the Biostatistics and Statistical Modelling organisation
Carry out functional responsibilities in accordance with applicable company guidelines and regulatory requirements
Plan, supervise, implement and monitor the statistical processes for multiple clinical trials

Skills

Biostatistics

Clinical Trial Design

Statistical Analysis

Clinical Development

Study Design

Regulatory Submissions

HA Submissions

Sponsor Experience

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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