Lead Biostatistician – Pharmacovigilance, PV

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🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $120k - $180k / year

⏰ 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

• Leads the statistical design, analysis, interpretation, and reporting of pharmacovigilance and safety-focused observational studies using complex longitudinal registry data • Collaborates with investigators, epidemiologists, clinicians, and clients to develop protocols, Statistical Analysis Plans (SAPs), and analytic strategies that support client objectives and regulatory commitments • Independently performs advanced statistical analyses and sample size/power calculations in accordance with SAPs and industry best practices • Provides strategic statistical leadership and independently makes sound statistical decisions related to safety analyses and real-world evidence generation • Oversees and mentors Biostatistician I/II analysts and other junior staff, ensuring quality, accuracy, and consistency of statistical analyses and documentation • Develops and implements standardized methodologies, analytical templates, and programming approaches to improve efficiency, reproducibility, and consistency across projects

🎯 Requirements

• PhD in Biostatistics, Statistics, Mathematics preferred; 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

• 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