Lead Biostatistician - PV Focus

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🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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

• Lead the statistical design, analysis, interpretation, and reporting of pharmacovigilance and safety-focused observational studies using complex longitudinal registry data • Collaborate with investigators, epidemiologists, clinicians, and clients to develop protocols, Statistical Analysis Plans (SAPs), and analytic strategies supporting client objectives and regulatory commitments • Independently perform advanced statistical analyses and sample size/power calculations in accordance with SAPs and industry best practices • Provide strategic statistical leadership and make independent statistical decisions related to safety analyses and real-world evidence generation • Oversee and mentor Biostatistician I/II analysts and other junior staff, ensuring quality, accuracy, and consistency of analyses and documentation • Develop and implement standardized methodologies, analytical templates, and programming approaches to improve efficiency, reproducibility, and consistency across projects

🎯 Requirements

• Master’s degree in Biostatistics, Statistics, or Mathematics required; PhD preferred • Minimum 5–8 years of applied statistical experience in clinical research, pharmaceutical, biotechnology, CRO, hospital, or academic settings required • Demonstrated experience leading complex observational research studies, equivalent to 3 years, required • Experience with complex longitudinal registry or real-world data required • Knowledge of retrospective and prospective observational study designs and related methodologies required • Advanced proficiency in R required; experience with SAS preferred • Experience with pharmacovigilance or safety-focused analysis project leadership preferred • 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 • Strong understanding of statistical methodology for observational and longitudinal data analyses • Ability to independently lead projects, prioritize competing deliverables, and manage multiple timelines • Strong scientific, analytical, problem-solving, leadership, and communication skills • Ability to collaborate across cross-functional teams and communicate complex statistical concepts to technical and non-technical audiences • Strong attention to detail and commitment to high-quality, reproducible analyses and documentation • Excellent written communication skills and adherence to best practices for statistical programming and code documentation • Ability to make independent judgments under limited supervision • Strong interpersonal and collaborative team-oriented skills • Must be legally authorized to work in the United States without sponsorship • Must be able to pass a comprehensive background check, including drug screening

🏖️ Benefits

• Remote work from home • Reasonable accommodation for disabilities during the application, interview, and employment process • No relocation benefits offered