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 4 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.
