VP, Biometrics
About The Position
The Vice President, Biometrics will build, resource, and oversee 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) 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.
Requirements
- Proven experience leading a biometrics function, with a PhD qualification or a Masters with equivalent industry experience
- Proven track record in oncology drug development (Phase I through Phase III).
- Comprehensive, up-to-date knowledge of ICH, FDA, EMA, and global regulatory guidance documents, with direct experience presenting statistical strategies to regulatory agencies.
- Deep expertise in advanced theoretical and applied statistics, including adaptive designs, Bayesian approaches, and master protocols.
- Expert-level understanding of statistical software (SAS, R, etc.) and industry data standards (CDISC).
- 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
- An entrepreneurial self-starter who balances a strong sense of urgency and rapid clinical execution with rigorous scientific standards and ethical integrity.
Nice To Haves
- Experience or strong familiarity with radiopharmaceutical/imaging clinical trial methodology is highly desirable.
Responsibilities
- Ensure highly effective and compliant global operations in biostatistics and clinical/statistical programming, establishing industry-best standard operating procedures (SOPs).
- Lead Biometrics participation in clinical development plans (CDPs), clinical protocols, investigator brochures, regulatory briefing documents, and scientific publications.
- Drive the development, implementation, and execution of robust statistical analysis plans (SAPs) that support clinical protocols, ensuring absolute data integrity, accuracy, and regulatory compliance.
- Provide specialized statistical guidance for the expanding Bicycle® Radioconjugate (BRC®) portfolio, incorporating imaging endpoints, dosimetry analysis, and theranostic study designs.
- 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).
- 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).
- Recruits, retains, and mentors a high-performing biostatistics and programming team, fostering a culture of scientific excellence, accountability, and continuous professional development.
- Cultivate strong collaborative relationships with external investigators, steering committees, and academic thought leaders, actively contributing to the broader biostatistics community.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Executive
