Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJob DescriptionAt 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 dataCollaborates with investigators, epidemiologists, clinicians, and clients to develop protocols, Statistical Analysis Plans (SAPs), and analytic strategies that support client objectives and regulatory commitmentsIndependently performs advanced statistical analyses and sample size/power calculations in accordance with SAPs and industry best practicesProvides strategic statistical leadership and independently makes sound statistical decisions related to safety analyses and real-world evidence generationOversees and mentors Biostatistician I/II analysts and other junior staff, ensuring quality, accuracy, and consistency of statistical analyses and documentationDevelops and implements standardized methodologies, analytical templates, and programming approaches to improve efficiency, reproducibility, and consistency across projectsHiring requirements:Education requirementsPhD in Biostatistics, Statistics, Mathematics is preferred. A master’s degree in these same areas is required.Experience requirementsMinimum 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 requiredDemonstrated knowledge of retrospective and prospective observational study designs and related methodologies required.Experience with causal inference theory and methods strongly preferredExperience supporting regulatory safety studies, post-authorization safetystudies (PASS), or related pharmacovigilance activities preferredExperience mentoring or supervising junior biostatisticians preferredCollaborative research experience with publications in peer-reviewed journals preferredAdvanced proficiency in R required; experience with SAS preferredKnowledge, Skills and AbilitiesStrong understanding of statistical methodology for observational and longitudinal data analysesKnowledge of pharmacovigilance principles, safety data evaluation, and real-world evidence generation preferredAbility to independently lead projects, prioritize competing deliverables, and manage multiple timelines effectivelyStrong scientific, analytical, problem-solving, leadership, and communication skillsDemonstrated ability to collaborate effectively across cross-functional teams and communicate complex statistical concepts to technical and non-technical audiencesStrong attention to detail and commitment to high-quality, reproducible analyses and documentationRequires excellent written communication skills and adherence to best practices for statistical programming and code documentationAbility to make independent judgments under limited supervisionStrong interpersonal skills and a collaborative team-oriented mindsetLocation: 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! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. 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