Biostatistics Manager

2 weeks ago


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

Luminary Group is in search of a skilled and seasoned Biostatistics Team Lead to join our esteemed client. In this pivotal role, you will be responsible for directing and overseeing the biostatistics and data management operations within the organization. Your expertise will be crucial in ensuring the design, analysis, and reporting of clinical trial data meets the highest standards of quality and regulatory compliance.

Key Responsibilities:
  • Lead and mentor a team of biostatisticians and data managers, fostering professional growth and conducting performance assessments.
  • Formulate and execute biostatistical and data management strategies for clinical trials spanning various therapeutic areas and phases.
  • Supervise 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 plans.
  • Conduct analyses of clinical trial data utilizing appropriate statistical techniques, ensuring the precision, consistency, and reliability of findings.
  • Guarantee adherence to regulatory standards and industry best practices concerning biostatistics and data management.
  • Collaborate with interdisciplinary teams to harmonize biostatistical and data management efforts within the clinical development continuum.
  • 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 practices.
  • Contribute to departmental projects and initiatives 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 calculations, randomization techniques, and statistical analyses.
  • Proficiency in statistical software such as SAS or R.
  • Familiarity with data management tools and clinical data standards.
  • Awareness of regulatory guidelines and requirements pertaining to biostatistics and data management.
  • Exceptional communication and interpersonal abilities, facilitating effective collaboration with cross-functional 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.


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