Senior Director Biometrics

Role Summary

The Senior Director Biometrics is a strategic leadership role responsible for overseeing all biometrics activities—including biostatistics, data management, and statistical programming—across clinical development programs. This position ensures the integrity, quality, and timely delivery of clinical data to support regulatory submissions, clinical trial operations, and decision-making processes. The Senior Director will collaborate cross-functionally with clinical, regulatory, medical, and project management teams to drive data-driven strategies and innovation.

Responsibilities

• Lead and manage the biometrics function, including biostatistics, data management, and statistical programming teams.
• Develop and implement biometrics strategies to support clinical development plans, regulatory submissions, and post-marketing activities.
• Oversee design, analysis, and interpretation of clinical trials, ensuring statistical rigor and compliance with regulatory standards.
• Establish and maintain best practices for data collection, management, and analysis, ensuring data integrity and quality.
• Collaborate with cross-functional teams (clinical, regulatory, medical, and project management) to align biometrics deliverables with program objectives.
• Provide expert guidance on statistical methodologies, protocol development, and study design.
• Represent biometrics in interactions with regulatory agencies, external partners, and key stakeholders.
• Mentor and develop biometrics staff, fostering a culture of excellence, innovation, and continuous improvement.
• Monitor industry trends and emerging technologies to enhance biometrics capabilities and processes.

Qualifications

• Advanced degree (PhD or MS) in Biostatistics, Statistics, Mathematics, or a related field.
• Extensive experience 10+ years in biometrics leadership roles within the pharmaceutical, biotechnology, or CRO industry.
• Proven track record in designing and analyzing clinical trials (Phase I-IV), including regulatory submissions (NDA/BLA/MAA).
• Expert knowledge of statistical software (e.g., SAS, R) and clinical data management systems.
• Strong understanding of global regulatory requirements (FDA, EMA, ICH guidelines).
• Exceptional leadership, communication, and organizational skills.
• Ability to work collaboratively in a fast-paced, matrixed environment.

Skills

• Strategic Thinking: Ability to set vision and direction for biometrics functions.
• Technical Expertise: Deep understanding of statistical methodologies and clinical data standards.
• Collaboration: Skilled at building relationships across disciplines and driving cross-functional initiatives.
• Problem Solving: Proactive in identifying challenges and implementing effective solutions.
• People Development: Committed to mentoring and growing high-performing teams.