We have a current opportunity for a AD Statistics Late Stage oncology on a permanent basis. The position will be based in NJ or can be remote. For further information about this position please apply.

Job Title: Associate Director, Statistics - Late Stage Oncology

Position Overview: We are seeking a highly skilled and motivated Associate Director of Statistics to join our Late Stage Oncology team. The successful candidate will play a critical role in the design, analysis, and interpretation of clinical trials, ensuring the highest standards of statistical rigor and scientific integrity.

Key Responsibilities:

• Lead the statistical strategy for late-stage oncology clinical trials
• Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to develop and execute clinical trial protocols.
• Provide statistical expertise in the design of clinical trials, including sample size calculations, randomization schemes, and statistical analysis plans.
• Analyze clinical trial data and interpret results, ensuring accurate and comprehensive reporting.
• Prepare and review statistical sections of clinical study reports, regulatory submissions, and publications.
• Ensure compliance with regulatory guidelines and industry standards for statistical practices.
• Mentor and provide guidance to junior statisticians and other team members.
• Stay current with advancements in statistical methodologies and oncology research.

Qualifications:

• Ph.D. or M.S. in Statistics, Biostatistics, or a related field.
• Minimum of 5 years of experience in the pharmaceutical or biotechnology industry, with a focus on oncology.
• Proven track record of leading statistical aspects of late-stage clinical trials.
• Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA).
• Proficiency in statistical software (e.g., SAS, R).
• Excellent communication and interpersonal skills.
• Ability to work effectively in a collaborative, fast-paced environment.

Preferred Qualifications:

• Experience with adaptive trial designs and Bayesian statistics.
• Publications in peer-reviewed journals.
• Experience in interactions with regulatory agencies.

Benefits:

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with company match.
• Opportunities for professional development and career advancement.
• Collaborative and inclusive work environment.