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Lead Biostatistician

2 months ago

Boston, Massachusetts, United States Luminary Group Full time
Job Overview

Luminary Group is on the lookout for a skilled and knowledgeable Biostatistics Team Lead to join our esteemed client. In this pivotal role, you will be instrumental in directing and overseeing the biostatistics and data management operations within the organization. Your primary responsibility will be to ensure the meticulous design, analysis, and reporting of clinical trial data, while maintaining the highest standards of quality and compliance with regulatory requirements.

Key Responsibilities:
  • Guide and supervise a team of biostatisticians and data management professionals, offering mentorship, support, and performance assessments.
  • Formulate and execute biostatistical and data management strategies for clinical trials spanning various therapeutic areas and stages.
  • Oversee the creation of clinical trial protocols, including sample size determinations and statistical analysis frameworks.
  • Review and endorse clinical trial documentation, such as data management strategies, data validation protocols, and statistical analysis frameworks.
  • Conduct analyses of clinical trial data utilizing suitable statistical techniques, ensuring the precision, consistency, and reliability of findings.
  • Guarantee adherence to regulatory standards and industry practices concerning biostatistics and data management.
  • Collaborate with interdisciplinary teams to synchronize biostatistical and data management functions within the clinical development lifecycle.
  • Provide statistical insights and assistance during regulatory discussions and submissions.
  • Engage in the formulation and evaluation of clinical study reports, statistical summary documents, and other regulatory submissions.
  • Remain informed about the latest developments in biostatistics and data management methodologies.
  • Contribute to departmental initiatives and efforts aimed at process enhancement.
Qualifications:
  • Master's degree or PhD in biostatistics, statistics, or a related discipline.
  • A minimum of 7 years of experience in biostatistics and data management within the pharmaceutical or biotechnology sectors.
  • Previous experience in a leadership or managerial capacity.
  • Comprehensive understanding of statistical methodologies applicable to clinical trials, including sample size estimation, randomization, and statistical analysis.
  • Proficiency in statistical software such as SAS or R.
  • Familiarity with data management tools and clinical data standards.
  • Awareness of regulatory guidelines and requirements pertinent to biostatistics and data management.
  • Exceptional communication and interpersonal abilities, with a talent for effective collaboration with diverse teams and external partners.
  • Strong analytical and decision-making skills.
  • Meticulous attention to detail and accuracy.
  • A record of publications in peer-reviewed journals is advantageous.