Luminary Group is seeking a talented and experienced Biostatistics Manager to join our client. As a Biometrics Manager, you will play a key role in leading and managing the biostatistics and data management functions within the company. You will be responsible for overseeing the design, analysis, and reporting of clinical trial data, ensuring high quality and regulatory compliance.
Responsibilities:
Lead and manage a team of biostatisticians and data managers, providing guidance, mentorship, 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, data validation plans, and statistical analysis plans
Analyze clinical trial data using appropriate statistical methods, ensuring accuracy, consistency, and reliability of results
Ensure compliance with regulatory guidelines and industry standards in relation to biostatistics and data management
Collaborate with cross-functional teams to integrate biostatistical and data management 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, statistical summary reports, and other regulatory documents
Stay up-to-date with the latest advancements in biostatistics and data management methodologies
Contribute to departmental initiatives and process improvement projects
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, randomization, and statistical analysis
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, with the ability to effectively collaborate with cross-functional teams and external stakeholders
Strong problem-solving and decision-making abilities
A high level of attention to detail and accuracy
Publication record in peer-reviewed journals is desirable
Seniority level
Director
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Primary and Secondary Education and Non-profit Organizations
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