About the Role
We are seeking an accomplished Principal Biostatistician to lead and contribute to the design, analysis, and reporting of clinical trials. In this leadership role, you will provide statistical expertise and guidance across multiple projects, ensuring scientific rigor and compliance with regulatory standards. Your contributions will play a critical role in shaping the success of our clinical programs and advancing innovative therapies.
Requirements
Experience: Minimum 8 years in biostatistics, with leadership experience in clinical trials.
Technical Skills: Proficiency in statistical programming (SAS, R), expertise in CDISC standards (SDTM, ADaM), and advanced statistical methodologies.
Education: Ph.D. or Master’s in Biostatistics, Statistics, or a related field.
Knowledge: In-depth understanding of regulatory guidelines and submissions (e.g., ICH, FDA, EMA).
Soft Skills: Exceptional problem-solving abilities, leadership, and communication skills.
Qualification
Experience with oncology, rare diseases, or other complex therapeutic areas.
Publication of peer-reviewed articles or conference presentations.
Familiarity with innovative trial designs, such as adaptive or Bayesian methods.
Responsibilities
Lead the statistical design and analysis of clinical trials, including sample size calculations, statistical analysis plans (SAPs), and interim and final analyses.
Provide strategic input into study protocols, ensuring statistical and scientific integrity.
Oversee the preparation, validation, and delivery of statistical deliverables for regulatory submissions (e.g., FDA, EMA).
Collaborate with cross-functional teams, including clinical, programming, and data management teams, to ensure alignment and seamless project execution.
Mentor and provide guidance to biostatistics and programming team members.