Biometrics Director

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Requirements:

• Master's or PhD in biostatistics, statistics, or a related field.
• Minimum of 7 years of experience in biostatistics and data management in the pharmaceutical or biotechnology industry.
• Prior experience in a leadership or management role.
• Strong knowledge of statistical methodologies used in clinical trials, including sample size calculation and randomization.
• Experience with statistical software such as SAS or R.
• Experience with data management tools and clinical data standards.
• Knowledge of regulatory guidelines and requirements related to biostatistics and data management.
• Excellent communication and interpersonal skills.
• Strong problem-solving and decision-making abilities.
• High level of attention to detail and accuracy.
• Publication record in peer-reviewed journals is desirable.

Responsibilities:

• Lead and manage a team of biostatisticians and data managers, providing guidance and performance evaluations.
• Develop and implement biostatistical and data management strategies for clinical trials across multiple therapeutic areas and phases.
• Oversee the design of clinical trial protocols, including sample size calculations and statistical analysis plans.
• Review and approve clinical trial documentation, including data management plans and statistical analysis plans.
• Analyze clinical trial data using appropriate statistical methods, ensuring accuracy and reliability.
• Ensure compliance with regulatory guidelines and industry standards.
• Collaborate with cross-functional teams to integrate activities within the clinical development process.
• Provide statistical expertise and support in regulatory interactions and submissions.
• Participate in the development and review of clinical study reports and other regulatory documents.
• Stay up-to-date with advancements in biostatistics and data management methodologies.
• Contribute to process improvement projects.