Lead Biostatistician – Pharmacovigilance

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🔥 22 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Serve as the statistical lead on high-profile pharmacovigilance (PV) and safety-focused projects • Lead the statistical design, analysis, interpretation, and reporting of observational studies • Collaborate with investigators, epidemiologists, clinicians, and clients • Independently perform advanced statistical analyses and sample size/power calculations • Provide strategic statistical leadership and independently make sound statistical decisions • Oversee and mentor Biostatistician I/II analysts and other junior staff • Develop and implement standardized methodologies and analytical templates

🎯 Requirements

• PhD in Biostatistics, Statistics, Mathematics is preferred • A master’s degree in these same areas is required • Minimum 5–8 years of applied statistical experience in clinical research, pharmaceutical, biotechnology, CRO, hospital or academic is required • Demonstrated experience leading complex observational research studies, equivalent to 3 years is required • Experience with Pharmacovigilance or safety-focused analyses project lead experience is preferred • Experience working with complex longitudinal registry or real-world data required • Demonstrated knowledge of retrospective and prospective observational study designs and related methodologies required • Experience with causal inference theory and methods strongly preferred • Experience supporting regulatory safety studies, post-authorization safety studies (PASS), or related pharmacovigilance activities preferred • Experience mentoring or supervising junior biostatisticians preferred • Collaborative research experience with publications in peer-reviewed journals preferred • Advanced proficiency in R required; experience with SAS preferred

🏖️ Benefits

• This role does not offer relocation benefits • 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 screening • Accelerating life sciences research • Solving complex analytical challenges • Increasing productivity in laboratories