Bicycle Therapeutics
Senior Director, Biostatistics
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Company Description
Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle® molecules attractive candidates for drug development. The company is evaluating nuzafatide pevedotin (formerly BT5528), a Bicycle® Drug Conjugate (BDC®) targeting EphA2, a historically undruggable target; a pipeline of Bicycle® Radioconjugates (BRCs) and imaging agents; zelenectide pevedotin (formerly BT8009), a BDC® targeting Nectin-4, a well-validated tumor antigen; and, through various partnerships, the use of Bicycle® technology to develop therapies to treat diseases in a range of therapeutic areas.
Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Massachusetts, USA. For more information, visit bicycletherapeutics.com.
Culture is key and all Bicycle employees actively embrace and role model our company values:
- We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.
- We are Dedicated to our Mission. You can’t change the world if you don’t have determination.
- We are One Team. We only succeed when we work together.
At Bicycle, we benefit from a hybrid style working arrangement, allowing our employees where possible the opportunity to collaborate and engage with their coworkers in person while also benefiting from the flexibility of home remote working. A typical hybrid arrangement for this role is 3 days onsite per week at our Cambridge, UK, with the remainder of your working week remote.
Job Description
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.
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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.
Qualifications
- 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 organizational goals.
- Problem-Solving: You solve systemic, organization-wide challenges, such as defining the statistical strategy for a pivotal trial or addressing complex regulatory questions.
- Strategic Impact: You contribute directly to organizational 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 organization-wide implications for our clinical programs.
- Leadership / Mentorship: You develop future organizational leaders, providing coaching to senior statistical professionals and ensuring robust succession planning for your function.
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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 organization confidently through major data readouts and regulatory submissions, providing clear direction and fostering enterprise-wide alignment.
Dedicated to our Mission
- Accountability: You ensure organizational 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 organization-wide commitment to our purpose, articulating a compelling quantitative vision that connects robust data directly to patient outcomes.
Additional Information
Benefits Overview
- Pension (12% employer contribution)
- Private Medical Insurance (PMI) (including optical and dental cover)
- Health Cash Plan
- Group Life Assurance (4x basic salary)
- Group Income Protection
- Employee Assistance Program (EAP)
- Cycle to Work scheme
- Access to subsidized gym membership
- Time off (28 days annual leave in addition to bank holidays & the option to buy up to 5 additional days annually)
- Competitive reward including annual company bonus
- Employee recognition schemes
- Enhanced parental leave policies
- Flexible working environment
- State-of-the-art campus environment with on campus restaurant and Montessori nursery
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.
Department: Development
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