Director of Biometrics

Position Overview :

We are seeking a highly skilled and experienced Director of Biometrics to lead our Biometrics team. This key leadership role will be responsible for overseeing all statistical and data management activities across the company’s oncology drug development programs.

The Director of Biometrics will work closely with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to ensure the integrity and quality of clinical data and support the successful development and approval of our therapeutic candidates.

The ideal candidate will have a strong background in biostatistics, data science, and clinical trial design, as well as experience in managing teams and collaborating with external partners, including regulatory agencies.

Key Responsibilities :

• Leadership and Strategy :
• Lead and manage the Biometrics department, including biostatistics, statistical programming, and data management teams.
• Develop and implement strategic plans for biometrics to support clinical development programs and regulatory submissions.
• Serve as a key member of the clinical leadership team, contributing to the overall clinical development strategy.
• Ensure compliance with regulatory requirements and industry standards in all biometrics activities.
• Statistical Analysis and Data Management :
• Provide statistical leadership in the design, analysis, and interpretation of clinical trials, ensuring robust and scientifically sound methodologies.
• Oversee the development of statistical analysis plans (SAPs), clinical study reports (CSRs), and regulatory submission documents.
• Ensure high-quality data management practices, including database design, data collection, and data validation processes.
• Collaborate with clinical operations and external vendors to ensure timely and accurate delivery of clinical trial data.
• Regulatory and Clinical Support :
• Represent the business in interactions with regulatory authorities, providing statistical expertise during regulatory submissions and meetings.
• Provide strategic input on clinical trial design, endpoint selection, and statistical considerations for regulatory filings and publications.
• Team Development and Collaboration :
• Mentor and develop the biometrics team, fostering a culture of scientific excellence and continuous learning.
• Collaborate effectively with internal and external stakeholders, including clinical development, regulatory affairs, medical affairs, and external vendors.
• Drive innovation in biometrics by staying up-to-date with the latest statistical methods, technologies, and industry trends.

Qualifications :

• Minimum of 7 years of experience in biometrics, with at least 2 years in a leadership role within the pharmaceutical or biotechnology industry.
• Proven track record of successful regulatory submissions and approvals, particularly in oncology drug development.
• Expertise in clinical trial design, statistical analysis, and data management, with a strong understanding of regulatory requirements (e.g., FDA, EMA).
• Demonstrated ability to lead cross-functional teams and manage external partners and vendors.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization.
• Strong problem-solving skills and a proactive approach to identifying and addressing challenges in clinical development.
• Experience with statistical programming languages (e.g., SAS, R) and clinical trial software (e.g., CDISC, Medidata) is highly desirable.
Vor 20 Tagen