Senior Director, Biostatistics

Your mission is to provide expert strategic and statistical leadership for Bicycle's clinical development portfolio. You will lead a team of biostatisticians, providing quantitative deep thinking to shape study designs, guide program strategy, and ensure the integrity of our clinical data. As a key leader in the Biometrics function, you will be instrumental in translating complex data into clear, actionable insights that drive our innovative therapies forward for patients. Your Responsibilities Team Leadership & Development - You will lead, coach, and mentor your team of biostatisticians, investing in their professional growth and fostering a culture of high performance and psychological safety. - You will set clear goals and strategic priorities for the biostatistics function, ensuring its work is directly aligned with departmental and organizational objectives. - You will champion the Bicycle Values in all that you do, acting as a role model and embedding a culture of collaboration, accountability, and innovation within your team. Statistical Strategy & Program Leadership - Serve as the program-level biostatistical lead for key development assets, providing strategic input and quantitative expertise to shape the clinical development plan. - Collaborate with senior leaders in Medical, Clinical Research, and Regulatory Affairs to address critical questions and support data-driven clinical decision-making. - Represent the biostatistics function in all regulatory interactions, including providing statistical expertise for meetings and authoring key sections of regulatory documents. Study Execution & Technical Oversight - Provide senior oversight for all study-level biostatistical activities, including work conducted by vendors, to ensure the highest standards of quality and timeliness. - Apply advanced statistical methods, including modeling and simulation, to solve challenging issues in study design, analysis, and interpretation. - Provide expert review and approval for key statistical documents, including protocols and Statistical Analysis Plans (SAPs), ensuring they are fit for purpose. - Extensive experience and a record of senior leadership in biostatistics within the biopharmaceutical industry, with a deep focus on oncology clinical trials. - Proven experience in people management and leading high-performing technical teams. - Demonstrated ability to develop and execute the statistical strategy for clinical development programs and translate complex data into clear, impactful insights. - Authoritative knowledge of advanced statistical methods, regulatory guidelines (GCP), and their application to all phases of clinical development. - Proficiency with statistical programming languages (e.g., R, SAS) and a deep understanding of simulation and modeling techniques. Competencies & Values: Knowledge & Expertise - Core Expertise: You guide the statistical and quantitative strategy across multiple functions, shaping the company's approach to clinical study design and data analysis. - Data / Insight: You provide foresight and strategic interpretation of complex clinical trial data, simulations, and statistical models to guide long-term development strategy. - Knowledge Sharing: You represent the Biostatistics function externally and internally as a thought leader, promoting best practices and enhancing Bicycle's scientific reputation. Job Complexity - Task / Project Delivery: You oversee a portfolio of clinical programs, ensuring that all biostatistical strategies are aligned, resourced, and executed to meet organisational goals. - Problem-Solving: You solve systemic, organisation-wide challenges, such as defining the statistical strategy for a pivotal trial or addressing complex regulatory questions. - Strategic Impact: You contribute directly to organisational strategy and direction by ensuring a cutting-edge, statistically robust approach is embedded across our clinical pipeline. Independence - Autonomy: You shape the cross-functional direction of clinical programs, participating in key strategic decisions on study design and data interpretation. - Decision-Making: You make enterprise-level decisions on statistical strategy and methodology that have organisation-wide implications for our clinical programs. - Leadership / Mentorship: You develop future organisational leaders, providing coaching to senior statistical professionals and ensuring robust succession planning for your function. Values & Behaviours One Team - Collaboration: You create alignment across multiple senior teams (Biometrics, Clinical, Medical, Regulatory), ensuring biostatistics is a seamless and strategic partner in our development engine. - Inclusive Leadership: You embed inclusivity and collaboration into the culture, acting as a role model for how to integrate diverse scientific and quantitative perspectives. - Mentorship / Support: You coach senior leaders and statistical experts, actively engaging in succession planning to build our future leadership pipeline. Adventurous - Innovation: You champion the adoption of innovative statistical methodologies and practices that have the potential to transform our approach to clinical development. - Risk-Taking: You take calculated, high-level risks, such as using novel study designs or advanced simulation techniques, to position our programs for success. - Change Leadership: You lead the organisation confidently through major data readouts and regulatory submissions, providing clear direction and fostering enterprise-wide alignment. Dedicated to our Mission - Accountability: You ensure organisational priorities for your programs remain directly aligned with our core mission, holding the wider team accountable for data integrity and quality. - Resilience: You sustain focus and determination during high-stakes challenges, providing a steadying influence through key clinical milestones and regulatory reviews. - Inspiration: You inspire organisation-wide commitment to our purpose, articulating a compelling quantitative vision that connects robust data directly to patient outcomes. has context menu