Senior Director, Biostatistics

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 5528), a Bicycle® Drug Conjugate (BDC®) targeting EphA2, a historically undruggable target; zelenectide pevedotin (formerly BT8009), a BDC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio conjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.

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

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.

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.

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…