Bicycle Therapeutics

Bicycle Therapeutics

VP, Biometrics

Lexington, MA, United States · Vp · Full-time

Sponsorship not specifiedDetected 7 days ago
PythonGCPData AnalysisStatisticsNegotiationVendor ManagementFDA RegulatorySASResearchLeadershipCommunicationCollaborationMentoringPublic SpeakingBiostatistics

About the role

  • 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.
  • Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Massachusetts, USA.

Responsibilities

  • 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.
  • 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.
  • 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.
  • Statistical Methodologies: Deep expertise in advanced theoretical and applied statistics, including adaptive designs, Bayesian approaches, and master protocols.
  • 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

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).
  • 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.
  • With the ability to bring a target through development lifecycle to a successful MMA.
  • 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.
  • 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.

Compensation

  • Competitive reward including annual company bonus
  • We have shared the expected recruitment base pay range for this full-time position based on the anticipated location.

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 the premiums covered by the Company
  • Health and Dependent Care Flexible Spending Accounts
  • Time off (eligibility to accrue up to 23 paid time off days per full year worked, the option to buy up to 5 additional days & 10 company nominated holidays)
  • Competitive reward including annual company bonus
  • Enhanced parental leave policies
  • Flexible working 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.
  • At Bicycle, base pay is just one component of the total reward package.

Company info

  • 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.
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