Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion’s growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.

Position Summary

The Vice President, Head of Biometrics will report to the Chief Medical Officer and be responsible for creating and implementing both the near-term and long-term strategic direction for Biostatistics, Statistical Programming, and Clinical Data Management across all therapeutic areas and phases of development while ensuring systems, capabilities, and resources are in place to optimize the design/ conduct and analysis/interpretation of clinical trials and clinical data, respectively. This is a strategic leadership role to shape the future of Biometrics at Fusion.

Key Responsibilities

• Serve as the strategic partner working closely with other relevant functions in providing statistical input into strategy, design and execution of clinical development plans and trial designs
• Provide expert statistical input/review/Q.C. to ensure proper statistical methods are applied, data quality meets or exceed industry and company standards, and data interpretation is accurate internally (e.g., clinical studies, programs, regulatory submissions, publications) and externally (e.g., response to health authorities, questions from collaborators/alliance partners, presentations to advisory panels, and to address business needs)
• Provide leadership to team of internal FTE’s, external contractors, and vendors accountable for statistics, statistical programming, and clinical data management including managing performance, developing people, hiring and integrating new team members and fostering Fusion values, mission, and culture
• Serve as the point of escalation to ensure the timeliness and accuracy of biometric deliverables
• Collaborate with partner functions to provide statistical programming, systems analysis and database management support for important Clinical Development, Operations, Safety, Medical Affairs deliverables (e.g., risk-based monitoring, signal-detection and validation by pharmacovigilance, potential application of machine learning to important clinical deliverables)
• Serve as the biometrics subject matter expert for the company; capable of representing the company both internally and externally (e.g., present analyses to regulatory agencies, investigators, and collaborations, lead development and adaptation of new statistical methodology in support of clinical development)
• Lead and/or author development of new procedures and process improvement (e.g., development of statistical standards such as SAPs, outputs; data sharing procedures for internal and external audiences; data QC prior to release) to meet the needs of an evolving Biometrics Department
• Build and supervise the Biometrics team
• Oversee biostatistical activities outsourced to CROs including review and check of biostatistical and programming related SOPs Direct and integrate input from Fusion study teams into statistical designs

Qualifications

• Advanced degree (e.g., MS, PhD) in Statistics, Biostatistics, or related field preferred
• 10 years of biometrics experience across academia and the pharmaceutical/biotech industry
• At least 5 years of management experience leading a team of biostatisticians or a biometrics function
• Extensive knowledge of Health Authority requirements (e.g., GCP, ICH, 21 CFR Part 11, EMA/CHMP regulations, CDISC standards)
• Experience with working with FDA/health authorities is highly preferred for this position
• Extensive experience in using statistical techniques including general linear models, predictive modeling, mixed effects models, multivariate analysis, etc
• Demonstrable experience in using data-science methodologies including clustering, classification,machine learning, etc.
• Strong programming skills in SAS required, R programming experience preferred
• Strong data visualization skills
• Knowledge and previous experience in integrating data from relevant databases is a plus
• Oncology experience highly desired
• Self-motivated- able to work autonomously and must thrive on challenge
• Ability to anticipate challenges and devise strategies for success
• Result and deadline-oriented
• Excellent presentation and communication skills
• Must be available to work in Boston at least one week a quarter

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.