Senior Director, Statistical Programming

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 pipeline of Bicycle® Radioconjugates (BRCs) and imaging agents; zelenectide pevedotin (formerly BT8009), a BDC® targeting Nectin-4; and, through partnerships, the use of Bicycle® technology to develop therapies across a range of therapeutic areas. Bicycle Therapeutics is headquartered in Cambridge, UK, with key functions and leadership located in Lexington, Massachusetts, USA.

Culture is key at Bicycle, where employees actively embrace and role model the company values: Adventurous, Dedicated to our Mission, and One Team. The company benefits from a hybrid working arrangement, typically 2-3 days onsite per week at the Lexington, MA office.

About the role

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 clinical trials and regulatory submissions.

Responsibilities

• 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.
• 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.
• Lead, coach, and mentor your team, investing in their professional growth and fostering a culture of high performance and psychological safety.
• Set clear goals and strategic priorities for your team, ensuring their work aligns with departmental and organizational objectives.
• Champion the Bicycle Values, acting as a role model and embedding a culture of collaboration, accountability, and innovation within your team.

Requirements

• Demonstrated deep expertise in statistical programming gained through significant and progressive experience in a biotech or pharmaceutical setting.
• Proven track record of leading the programming strategy for clinical development programs, preferably within oncology.
• Expert-level knowledge of SAS programming and CDISC data standards (SDTM/ADaM), with extensive experience preparing data for regulatory submissions (e.g., NDA/BLA).
• Substantial experience in managing CROs and external vendors, including technical oversight, governance, and relationship management.
• Proven leadership experience, with the ability to mentor programmers, set strategic direction for a team, and influence cross-functional partners.

Skills & Competencies

• Knowledge: Apply expert knowledge of statistical programming and clinical development to set functional strategy and solve complex, multi-faceted problems. Deep understanding of the regulatory landscape and its impact on programming deliverables.
• Job Complexity: Manage a portfolio of complex clinical programs and address abstract challenges requiring in-depth evaluation of variable factors. Anticipate future needs and develop innovative, long-range solutions.
• Independence: Operate with a high degree of independence, aligning team strategy with broader departmental and company goals. Trusted to make significant decisions regarding project execution, resource allocation, and vendor management.
• Values & Behaviours: Role model for the Bicycle Values, leading by example to create an inclusive and high-performing team environment. Build strong, influential relationships with senior stakeholders and represent the function with credibility.

Benefits

• 401(k) plan with a 4% Company match and immediate vesting.
• Medical, dental, and vision insurance for eligible employees and their families, with 100% of premiums covered by the Company.
• Health and Dependent Care Flexible Spending Accounts.
• Employee Assistance Program (EAP).
• Time off: eligibility to accrue up to 23 paid time off days per full year worked, option to buy up to 5 additional days, and 10 company-nominated holidays.
• 10 Company holidays.
• Competitive reward including annual company bonus.
• Employee recognition schemes.
• Enhanced parental leave policies.
• Flexible working environment.
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

Pay

Salary Range: $215,000 - $270,000