Lead Biostatistician - Pharmacovigilance (PV) Focus

Work Schedule 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 biostatisticians preferred Collaborative research experience with publications in peer-reviewed journals preferred Advanced proficiency in R required; experience with SAS preferred Knowledge, Skills and Abilities Strong understanding of statistical methodology for observational and longitudinal data analyses Knowledge of pharmacovigilance principles, safety data evaluation, and real-world evidence generation preferred Ability to independently lead projects, prioritize competing deliverables, and manage multiple timelines effectively Strong scientific, analytical, problem-solving, leadership, and communication skills Demonstrated ability to collaborate effectively 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 Requires 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 skills and a collaborative team-oriented mindset Location: Remote from home in the US! 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. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! 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