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Senior Director of Biometrics and Data Science

2 months ago

San Diego, California, United States Luminary Group Full time
Job Description

Luminary Group is seeking a highly skilled and experienced Senior Biometrics Director to lead our biostatistics and data management functions. As a Biometrics leader, you will play a key role in overseeing the design, analysis, and reporting of clinical trial data, ensuring high quality and regulatory compliance.

Key Responsibilities:
  • Team Leadership: Lead and manage a team of biostatisticians and data managers, providing guidance, mentorship, and performance evaluations.
  • Biostatistical and Data Management Strategies: Develop and implement biostatistical and data management strategies for clinical trials across multiple therapeutic areas and phases.
  • Protocol Design: Oversee the design of clinical trial protocols, including sample size calculations and statistical analysis plans.
  • Documentation Review: Review and approve clinical trial documentation, including data management plans, data validation plans, and statistical analysis plans.
  • Data Analysis: Analyze clinical trial data using appropriate statistical methods, ensuring accuracy, consistency, and reliability of results.
  • Regulatory Compliance: Ensure compliance with regulatory guidelines and industry standards in relation to biostatistics and data management.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams to integrate biostatistical and data management activities within the clinical development process.
  • Regulatory Interactions: Provide statistical expertise and support in regulatory interactions and submissions.
  • Reporting and Documentation: Participate in the development and review of clinical study reports, statistical summary reports, and other regulatory documents.
  • Professional Development: Stay up-to-date with the latest advancements in biostatistics and data management methodologies.
  • Departmental Initiatives: Contribute to departmental initiatives and process improvement projects.

Requirements:

  • Education: Master's or PhD in biostatistics, statistics, or a related field.
  • Experience: Minimum of 7 years of experience in biostatistics and data management in the pharmaceutical or biotechnology industry.
  • Leadership Experience: Prior experience in a leadership or management role.
  • Statistical Knowledge: Strong knowledge of statistical methodologies used in clinical trials, including sample size calculation, randomization, and statistical analysis.
  • Technical Skills: Experience with statistical software such as SAS or R, and data management tools and clinical data standards.
  • Regulatory Knowledge: Knowledge of regulatory guidelines and requirements related to biostatistics and data management.
  • Communication Skills: Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
  • Problem-Solving Skills: Strong problem-solving and decision-making abilities.
  • Attention to Detail: A high level of attention to detail and accuracy.
  • Publication Record: Publication record in peer-reviewed journals is desirable.