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AD Statistics Late Stage oncology

EPM Scientific
Bernards, NJ Full Time
POSTED ON 4/9/2025
AVAILABLE BEFORE 5/8/2025

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.
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