Senior Director, Statistical Programming

Company Description

About Bicycle Therapeutics 

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. 

Working Classification:

At Bicycle, we benefit from a hybrid style working arrangement, allowing employees where possible the opportunity to collaborate and engage with their coworkers in person while also benefiting from the flexibility of remote working. A typical hybrid arrangement for this role is 2-3 days onsite per week at our Lexington, MA office, with the remainder of your working week remote.

Job Description

Your mission is to provide strategic and technical leadership for the statistical programming function, driving the delivery of high-quality data and analysis for Bicycle's clinical portfolio. You will ensure operational excellence across all programming activities, serve as a key strategic partner to Biostatistics and Clinical Development, and lead and mentor a team of programmers to support the successful execution of our clinical trials and regulatory submissions.

YOUR RESPONSIBILITIES  

Strategic & Technical Leadership

• Provide strategic leadership and hold accountability for all statistical programming deliverables for assigned clinical development programs, ensuring timelines, quality, and compliance are met.
• Serve as the senior technical expert on CDISC standards (SDTM, ADaM), programming methodologies, and data submission strategies, guiding the team and vendors on complex implementation challenges.
• Partner with the Biometrics Lead to define and execute the long-term vision and strategy for the statistical programming function, including resource planning, technology adoption, and talent development.

Operational Excellence & Process Innovation

• Drive the strategy for functional excellence by developing, implementing, and optimizing global Standard Operating Procedures (SOPs), tools, and innovative workflows to enhance efficiency and quality.
• Oversee the strategic selection and governance of CROs and external vendors, ensuring a harmonized approach to programming and holding partners accountable for high-quality, timely deliverables.
• Ensure all statistical programming activities and documentation are inspection-ready, providing senior oversight for data integrity and demonstrable compliance with ICH/GCP guidelines.

Team Leadership & Development

• You will lead, coach, and mentor your team, investing in their professional growth and fostering a culture of high performance and psychological safety.
• You will set clear goals and strategic priorities for your team, ensuring their work is directly aligned with departmental and organisational 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.

WHO ARE YOU: SKILLS & COMPETENCIES

Knowledge:

• You apply expert knowledge of statistical programming and clinical development to set functional strategy and solve complex, multi-faceted problems. You have a deep understanding of the regulatory landscape and its impact on programming del