Lead Biostatistics Manager and Data Strategist

7 days ago


Étreux, Hauts-de-France, United States Luminary Group LLC Full time

Luminary Group LLC is a renowned pharmaceutical company seeking an exceptional Biostatistics Manager to drive our biometrics and data management functions forward. As a key member of our team, you will be responsible for overseeing the design, analysis, and reporting of clinical trial data, ensuring high-quality results that meet regulatory compliance standards.

  • You will lead and manage a team of biostatisticians and data managers, providing guidance, mentorship, and performance evaluations to ensure they are equipped to deliver outstanding results.
  • Develop and implement biostatistical and data management strategies for clinical trials across multiple therapeutic areas and phases, staying up-to-date with the latest advancements in methodologies.
  • Oversee the design of clinical trial protocols, including sample size calculations and statistical analysis plans, to ensure accuracy and reliability of results.
  • Review and approve clinical trial documentation, including data management plans, data validation plans, and statistical analysis plans, to guarantee compliance with regulatory guidelines and industry standards.
  • Analyze clinical trial data using appropriate statistical methods, ensuring consistency and reliability of results.
  • Collaborate with cross-functional teams to integrate biostatistical and data management activities within the clinical development process, driving seamless communication and coordination.
  • Provide statistical expertise and support in regulatory interactions and submissions, ensuring that our data meets the highest standards of quality and integrity.
  • Participate in the development and review of clinical study reports, statistical summary reports, and other regulatory documents, contributing to the advancement of our company's research and development initiatives.
  • Maintain a deep understanding of regulatory guidelines and requirements related to biostatistics and data management, ensuring that our practices remain compliant and best-in-class.

Requirements:

  • You hold a Master's or PhD in biostatistics, statistics, or a related field, with a strong foundation in statistical methodologies used in clinical trials.
  • You have a minimum of 7 years of experience in biostatistics and data management in the pharmaceutical or biotechnology industry, with a proven track record of delivering high-quality results.
  • Your prior experience in a leadership or management role has equipped you with strong leadership and communication skills, allowing you to effectively collaborate with cross-functional teams and external stakeholders.
  • You possess excellent problem-solving and decision-making abilities, with a keen eye for detail and accuracy.
  • A publication record in peer-reviewed journals is desirable, demonstrating your expertise and contributions to the field.

We offer a competitive salary range of $120,000 - $180,000 per year, depending on your level of experience and qualifications. This is a full-time position, offering a comprehensive benefits package, opportunities for professional growth and development, and the chance to work with a talented team of professionals who share your passion for advancing medical research and development.



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