Lead Biostatistician – PV Focus

🔥 11 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Lead 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, and analytic strategies • Independently perform advanced statistical analyses and sample size/power calculations in accordance with SAPs and industry best practices • Provide strategic statistical leadership and make statistical decisions related to safety analyses and real-world evidence generation • Support long-term post-authorization safety studies and other regulatory commitments • Oversee and mentor Biostatistician I/II analysts and other junior staff • Develop and implement standardized methodologies, analytical templates, and programming approaches to improve efficiency, reproducibility, and consistency across projects • Work collaboratively with cross-functional teams to generate high-quality, scientifically rigorous real-world evidence

🎯 Requirements

• Master’s degree in Biostatistics, Statistics, or Mathematics required • PhD in Biostatistics, Statistics, or Mathematics preferred • Minimum 5–8 years of applied statistical experience in clinical research, pharmaceutical, biotechnology, CRO, hospital, or academic settings • Equivalent to 3 years of experience leading complex observational research studies • Experience working with complex longitudinal registry or real-world data • Knowledge of retrospective and prospective observational study designs and related methodologies • Advanced proficiency in R required • Experience with SAS preferred • Experience with pharmacovigilance or safety-focused analyses 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 • Knowledge of pharmacovigilance principles, safety data evaluation, and real-world evidence generation preferred • 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 in the US • Career resources and support to achieve individual career goals • Reasonable accommodation for disabilities during the application/interview process and employment • Equal employment opportunity and non-discrimination protections

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