Senior Manager of Biostatistics

1 week ago


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

Luminary Group is on the lookout for a skilled and seasoned Biostatistics Team Lead to become an integral part of our client’s organization. In this pivotal role, you will be at the forefront of managing and directing the biostatistics and data management operations within the company. Your expertise will be crucial in guiding the design, analysis, and reporting of clinical trial data, ensuring adherence to high standards and regulatory requirements.

Key Responsibilities:
  • Oversee and mentor a team of biostatisticians and data management professionals, fostering their development and conducting performance assessments.
  • Formulate and execute biostatistical and data management strategies for clinical trials spanning various therapeutic areas and stages.
  • Supervise the creation of clinical trial protocols, including calculations for sample sizes and statistical analysis frameworks.
  • Evaluate and endorse clinical trial documentation, such as data management strategies, validation plans, and statistical analysis frameworks.
  • Conduct analyses of clinical trial data utilizing suitable statistical techniques, ensuring the precision, consistency, and reliability of outcomes.
  • Guarantee compliance with regulatory standards and industry practices concerning biostatistics and data management.
  • Collaborate with multidisciplinary teams to incorporate biostatistical and data management efforts within the clinical development lifecycle.
  • Provide statistical guidance and support during regulatory discussions and submissions.
  • Engage in the creation and assessment of clinical study reports, statistical summaries, and other regulatory documentation.
  • Remain informed about the latest developments in biostatistics and data management methodologies.
  • Contribute to departmental initiatives and process enhancement projects.
Qualifications:
  • Master's 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.
  • In-depth knowledge of statistical methods applied in clinical trials, including sample size determination, randomization, and statistical analysis.
  • Proficiency in statistical software such as SAS or R.
  • Familiarity with data management tools and clinical data standards.
  • Understanding of regulatory guidelines and requirements pertaining to biostatistics and data management.
  • Exceptional communication and interpersonal abilities, with a proven track record of 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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