Lead Biostatistician - Pharmacovigilance (PV) Focus

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Standard (Mon-Fri) Environmental Conditions
Office Job Description
Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

More about our CorEvitas team:

The Biostatistics team for the Real-World Science department uses specialized statistical expertise to perform analyses such as assessing prescribing patterns, comparing effectiveness between treatments, and investigating differences in safety outcomes using complex longitudinal prospective and registry data. The team is comprised of key focus areas: query work, pharmacovigilance, and registry coordination.

What will you do in this role with our CorEvitas team?

The Lead Biostatistician will serve as the statistical lead on high-profile pharmacovigilance (PV) and safety-focused projects and will work collaboratively with cross-functional teams to support long-term post-authorization safety studies (PASS) and other regulatory commitments. This individual will independently design studies, develop statistical analysis plans, oversee analyses, and provide strategic statistical leadership to ensure high-quality and scientifically rigorous real-world evidence generation. A few key responsibilities are listed below.

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

Hiring requirements:

Education requirements

PhD in Biostatistics, Statistics, Mathematics is preferred. A master’s degree in these same areas is required.

Experience requirements

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 biosta