Vice President, Biometrics

City Therapeutics is a biopharmaceutical company harnessing next-generation engineering to improve and expand the reach of RNAi-based medicines. The company is building a pipeline of innovative RNAi therapeutics to make a significant impact for patients across multiple therapeutic areas. Co-founded by pioneering executives and scientists in RNAi, City Therapeutics is based in Cambridge, MA, and has raised $140 million from leading life sciences investors.

The Vice President, Biometrics will serve as the senior leader responsible for biometrics activities at City Therapeutics, encompassing biostatistics, and statistical programming, . This individual will report to CMO and be a key strategic partner to Clinical Development, Clinical Operation, Regulatory Affairs, and Medical Affairs — driving the design, execution, analysis, and reporting of clinical trials across the portfolio.

The VP will establish and scale the Biometrics infrastructure, including internal capabilities, vendor strategy, processes, and systems. This role requires both deep technical expertise and the leadership acumen to influence enterprise-level development decisions, lead related regulatory interactions, and build a high-performing team in a fast-growing organization.

Strategic Leadership & Function Building

• →Define and execute the strategic vision for the Biometrics function, aligning capabilities with City Therapeutics' clinical development goals and pipeline priorities.
• →Build and lead an internal team of biostatisticians, statistical programmers, and data managers; develop hiring plans commensurate with pipeline growth.
• →Establish and continuously improve biometrics processes, SOPs, data standards (CDISC/CDASH/SDTM/ADaM), and quality frameworks.
• →Partner with the CMO, Clinical Development, Clinical Operations and Regulatory Affairs to align biometrics strategy with overall program objectives.

Biostatistics & Statistical Programming

• →Provide statistical leadership and oversight for all clinical trials, including Phase 1–3 and registration studies.
• →Lead the design of clinical trials, including sample size determination, randomization, adaptive design methodology, and endpoint strategy.
• →Author and review Statistical Analysis Plans (SAPs), protocols, and clinical study reports (CSRs) to ensure statistical rigor and regulatory compliance.
• →Drive innovative approaches to trial design, such as seamless adaptive designs, and platform trials where appropriate.
• →Oversee statistical programming teams to ensure accurate, validated, and audit-ready CDISC-compliant datasets (SDTM and ADaM) and TLFs.

Regulatory & Submission Leadership

• →Lead biometrics contributions to global regulatory submissions, including INDs, NDAs, BLAs, MAAs, and agency briefing documents.
• →Represent City Therapeutics Biometrics in interactions with the FDA, EMA, and other health authorities; lead statistical discussions during regulatory meetings.
• →Ensure all deliverables meet regulatory requirements, including 21 CFR Part 11, ICH E9(R1), ICH E6(R2), and applicable FDA/EMA guidance.
• →Provide statistical input for labeling discussions and post-approval commitments.
• →Vendor & Operational Management
• →Develop and manage the CRO and biometrics vendor strategy, including vendor selection, oversight, and performance management.
• →Negotiate contracts and oversee budgets for all outsourced biometrics activities.
• →Implement risk-based quality oversight frameworks to ensure high-quality, on-time delivery by external partners.
• →Collaborate closely with Clinical Development, Clinical Operations, Medical Affairs, Translational Medicine, and Commercial to support data-driven decision-making across the organization.
• →Contribute to business development activities, including target assessment, due diligence, and partnership evaluations requiring quantitative analysis.
• →Represent Biometrics at governance committees, portfolio reviews, and executive leadership meetings.

Qualifications

• →PhD, MS, or equivalent advanced degree in Biostatistics, Statistics, or a closely related quantitative field.
• →Minimum of 12 years of experience in biometrics within the pharmaceutical or biopharmaceutical industry, with at least 5 years in a senior leadership role overseeing biostatistics, programming, and/or data management.
• →Demonstrated success leading biometrics for at least one NDA, BLA, or equivalent global regulatory submission resulting in approval.
• →Deep expertise in clinical trial design (including adaptive designs), statistical methodology, and regulatory statistics (ICH E9, E9(R1), E8).
• →Extensive experience with CDISC standards (CDASH, SDTM, ADaM) and regulatory submission requirements.
• →Proven track record building and leading high-performing biometrics teams, internally and through CRO partnerships.
• →Strong experience with FDA, EMA, and global health authority interactions on statistical matters.
• →Proficiency in SAS; experience with R and other programming languages a plus.
• →Exceptional communication skills with the ability to translate complex statistical concepts for non-statistical audiences.