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.