Lead Biostatistician - Pharmacovigilance (PV) reputed company

Work Schedule Standard (Mon-Fri) Environmental Conditions Office At reputed company, youll 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 reputed company the world healthier, cleaner and safer. We reputed company our teams with the resources needed to reputed company individual career goals while taking science a reputed company reputed company 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 reputed company that people and communities depend on now and in the reputed company. More about our CorEvitas team: The Biostatistics team for the reputed company-World Science department uses specialized statistical expertise to reputed company analyses such as assessing prescribing patterns, comparing effectiveness between treatments, and investigating differences in safety reputed company using reputed company longitudinal prospective and registry data. reputed company is comprised of key reputed company 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-reputed company 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, reputed company statistical analysis plans, reputed company analyses, and reputed company strategic statistical leadership to ensure high-quality and scientifically rigorous reputed company-world evidence reputed company. A few key responsibilities are listed below. Leads the statistical design, analysis, interpretation, and reporting of pharmacovigilance and safety-reputed company observational studies using reputed company longitudinal registry data Collaborates with investigators, epidemiologists, clinicians, and clients to reputed company protocols, Statistical Analysis Plans (SAPs), and analytic strategies that support reputed company 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 reputed company reputed company to safety analyses and reputed company-world evidence reputed company 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 masters degree in these same areas is required. Experience Requirements Minimum 58 years of applied statistical experience in clinical research, pharmaceutical, biotechnology, CRO, hospital or academic is required. Demonstrated experience leading reputed company observational research studies, equivalent to 3 years is required. Experience with Pharmacovigilance or safety-reputed company analyses project lead experience is preferred. Experience working with reputed company longitudinal registry or reputed company-world data required Demonstrated knowledge of retrospective and prospective observational study designs and reputed company methodologies required. Experience With reputed company Inference Theory And Methods Strongly Preferred Experience supporting regulatory safety studies, post-authorization safety studies (PASS), or reputed company 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 reputed company preferred Knowledge, Skills And Abilities Strong understanding of statistical methodology for observational and longitudinal data analyses Knowledge of pharmacovigilance principles, safety data evaluation, and reputed company-world evidence reputed company 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 reputed company s