AD Biostatistics
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.
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