AD Biostatistics

Remote, USA Full-time
About the position We have a current opportunity for a AD Biostatistics on a permanent basis. The site location is in New Jersey. This position can be remote or hybrid on site. We're seeking talented Biostatisticians that have pharma industry experience in Oncology early/late phase. For further information about this position please apply. Responsibilities • Provide statistical leadership and support for oncology clinical trials, including study design, statistical analysis plans, and data interpretation. • Collaborate with clinical teams to develop case report forms and ensure accurate data collection. • Conduct statistical analyses and provide input for clinical study reports, scientific presentations, and manuscripts. • Lead discussions with regulatory authorities and serve as a statistical responder in FDA advisory committee meetings. • Develop and implement statistical standard operating procedures (SOPs) and contribute to process improvements. • Mentor and develop junior biostatisticians and other team members. • Stay current with advancements in biostatistics and oncology research to ensure the application of best practices. Requirements • Ph.D. or Master's degree in Biostatistics, Statistics, or a related field. • Minimum of 8 years of experience in biostatistics, with at least 5 years in the pharmaceutical or biotechnology industry. • Strong knowledge of statistical methods and their application in clinical trials. • Experience with regulatory submissions and interactions with health authorities. • Proficiency in statistical software (e.g., SAS, R). • Excellent communication and leadership skills. • Ability to work collaboratively in a cross-functional team environment. Nice-to-haves • Experience in oncology clinical trials. • Familiarity with FDA and EMA guidelines for drug development. • Demonstrated ability to lead and manage multiple projects simultaneously. Benefits • Competitive salary and performance-based bonuses. • Comprehensive health, dental, and vision insurance. • 401(k) with company match. • Professional development opportunities. • Flexible work arrangements. Apply tot his job
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