Senior Director, Biometrics

The Senior Director, Biometrics at Senti Bio is responsible for strategic and operational leadership in the Biometrics function, which includes overseeing Biostatistics, Statistical Programming, and Data Management teams. This person ensures the delivery of high-quality data and analyses, collaborates on clinical trial designs, and prepares documents for regulatory submissions. You’ll also lead innovation in statistical methodologies and foster a culture of excellence within your team.

Candidates for the Senior Director, Biometrics position at Senti Bio should have a Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field. A minimum of 10 years of experience in clinical development is preferred, especially in oncology. Proven expertise in statistical methodologies, data management, and CDISC standards is essential alongside strong leadership and mentoring skills.

The Senior Director, Biometrics at Senti Bio plays a critical role in designing and executing clinical trials. This includes contributing to protocol development, statistical analysis plans, and preparing study reports. The director will also be involved in driving the biometrics strategy for regulatory submissions, ensuring that the trials are grounded in solid statistical principles and comply with global regulatory requirements.

At Senti Bio, the base salary range for the Senior Director, Biometrics role is between $280,000 and $310,000. Additional compensation includes an annual target bonus and potential equity options. Starting pay varies based on factors such as skills, education, and experience level, and demonstrates our commitment to supporting our employees as we grow.

Senti Bio fosters a collaborative and empathetic work environment. As a Senior Director, Biometrics, you can expect to work with supportive colleagues who value teamwork and professional development. The company encourages innovation and continuous learning, making it an excellent place for leaders who aim to mentor high-performing teams.

To effectively manage tight deadlines, I prioritize clear communication with my team and cross-functional partners. I would break down tasks into manageable milestones and ensure everyone understands their responsibilities. Regular check-ins and adjustments based on project needs help keep us on track while maintaining quality standards.

In my past roles, I have led multiple successful regulatory submissions to agencies such as the FDA and EMA. I focus on thorough preparation of integrated summaries and responding to regulatory queries with accurate, well-supported data. Understanding the regulatory landscape is key to ensuring compliance and facilitating smooth review processes.

I once led a project involving biostatisticians, clinical researchers, and regulatory experts to design a complex oncology trial. By fostering an open dialogue and encouraging input from all areas, we developed a robust study protocol that gained quick approval and was executed successfully within the timeline.

I’ve championed the use of advanced visualization tools and machine learning techniques to analyze clinical trial data, which has not only enhanced our analysis capabilities but also improved decision-making speed. By making complex data easily interpretable, we keep stakeholders informed and engaged.

Mentoring involves understanding the unique strengths and growth areas of each team member. I prioritize regular one-on-one check-ins, provide constructive feedback, and create opportunities for professional development. Building a culture of collaboration encourages team members to share ideas and learn from one another.

Ensuring compliance with CDISC standards starts with training the team on best practices and the importance of adherence. I regularly review our processes for data collection and management, ensuring we implement consistent SOPs that align with CDISC guidelines, which facilitates smooth regulatory review.

When facing challenges during trial design, I stress the importance of flexibility and open communication. Engaging with the team to brainstorm alternative strategies often reveals creative solutions. I also draw on data from past experiences to inform our designs and improve our approaches.

Key metrics for evaluating clinical trial success include data quality, regulatory compliance timelines, participant recruitment rates, and adherence to the study protocol. I believe it's essential to balance these quantitative measures with qualitative feedback from the team to enhance future trials.

Staying current involves actively participating in industry conferences, engaging with professional networks, and subscribing to relevant journals. I encourage my team to share insights and knowledge gained from these sources, fostering a culture of continuous learning and adaptation.

I strive for clarity and engagement in my communication. I use visuals to help simplify complex data and frame the narrative around our goals and findings. Tailoring my presentation to the audience ensures that stakeholders from different backgrounds can grasp the critical insights and their implications.