Job DescriptionThe Vice President, Biometrics will build, resource, oversee, and play a hands on role for the Biometrics organization. This leader holds ultimate accountability for clinical study designs, statistical methodologies, data analysis, and interpretation of results in close collaboration with partner functions across Clinical Development, Operations, and Regulatory Affairs.
As a key member of the Development Leadership Team, the VP provides strategic statistical input into Bicycle's drug development portfolio, representing the company in interactions with global Health Authorities (FDA, EMA, MHRA, RoW agencies) and contributing to the advancement of our oncology and radiopharmaceutical clinical pipelines. Additionally, this role supports early-stage research and translational sciences as required.
The ideal candidate possesses deep global clinical development expertise in oncology, combined with an outstanding track record of managing complex portfolios, driving innovation in applied statistical methodologies (including adaptive designs), and leading teams in a high-growth, agile biotechnology environment. Experience in Bayesian Trial design and radiopharmacology experience is preferred.
KEY RESPONSIBILITIES - Operational Leadership: Ensure highly effective and compliant global operations in biostatistics and clinical/statistical programming, establishing industry-best standard operating procedures (SOPs). Maintaining inspection-ready documentation and ensuring ICH GCP compliant, demonstrable data flow and data governance stewardship across the portfolio
- Strategic Input: Lead and actively contribute to Biometrics participation in clinical development plans (CDPs), clinical protocols, investigator brochures, regulatory briefing documents, and scientific publications.
- Statistical Integrity: Drive the development, implementation, and execution of robust statistical analysis plans (SAPs) that support clinical protocols, ensuring absolute data integrity, accuracy, and regulatory compliance.
- Radiopharmaceutical and BRC Support: Provide specialized statistical guidance for the expanding Bicycle® Radioconjugate (BRC®) portfolio, incorporating imaging endpoints, dosimetry analysis, and theranostic study designs.
- CRO & Vendor Management: Oversee the strategic selection and management of CRO partners, holding accountability for the quality, consistency, and timeliness of external programming deliverables (such as SDTM/ADaM datasets and TFLs).
- Regulatory Advocacy: Represent Bicycle as the lead statistical expert in interactions with global regulatory bodies (FDA, EMA, MHRA), aligning statistical strategies with current guidelines (including Project Optimus).
- Team Building & Mentorship: Recruits, retains, and mentors a high-performing biostatistics and programming team, fostering a culture of scientific excellence, accountability, and continuous professional development.
- External Engagement: Cultivate strong collaborative relationships with external investigators, steering committees, and academic thought leaders, actively contributing to the broader biostatistics community.
Qualifications- Background: Proven experience leading a biometrics function, with a PhD qualification or a Masters with equivalent industry experience. A hands on leader who is able to support day to day statistical tasks.
- Clinical Expertise: Proven track record in oncology drug development (Phase I through Phase III). Experience or strong familiarity with radiopharmaceutical/imaging clinical trial methodology is highly desirable. With the ability to successfully operate in a matrixed clinical development environment.
- Regulatory Acumen: Comprehensive, up-to-date knowledge of ICH, FDA, EMA, and global regulatory guidance documents, with direct experience presenting statistical strategies to regulatory agencies. With the ability to bring a target through development lifecycle to a successful MMA.
- Statistical Methodologies: Deep expertise in advanced theoretical and applied statistics, including adaptive designs, Bayesian approaches, and master protocols.
- Technical Proficiency: Expert-level understanding of statistical software (SAS, R, Python) and industry data standards (CDISC), with experience leading open-source package validation and modern submission standards.
- Leadership & Influence: Highly collaborative leader with exceptional interpersonal, communication, and negotiation skills; a proven ability to lead by example and thrive in a fast-paced, cross-functional environment
- Urgency & Quality: An entrepreneurial self-starter who balances a strong sense of urgency and rapid clinical execution with rigorous scientific standards and ethical integrity., with full compliance of ICH GCP.
Additional Information- State-of-the-art campus environment with on campus restaurant and Montessori nursery
- Flexible working environment
- Competitive reward including annual company bonus
- Employee recognition schemes
- 28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually
- Employer contribution to pension (employee does not have to contribute)
- Life assurance cover 4x basic salary
- Private Medical Insurance, including optical and dental cover
- Enhanced parental leave policies
- Group income protection
- Employee assistance program
- Health Cash Plan
- Access to company subsidized gym membership
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
- Cycle to work scheme
