City Therapeutics

Vice President, Biometrics

Cambridge, Massachusetts, United States · Exec

Sponsorship not specified$311k-$360kDetected 8 days ago

StatisticsBusiness DevelopmentClinical TrialsFDA RegulatorySASLeadershipCommunicationBiostatisticsRegulatory Affairs

About the role

The Vice President, Biometrics will serve as the senior leader responsible for biometrics activities at City Therapeutics, encompassing biostatistics, and statistical programming,.
The VP will establish and scale the Biometrics infrastructure, including internal capabilities, vendor strategy, processes, and systems.

Strategic Leadership & Function Building
Build and lead an internal team of biostatisticians, statistical programmers, and data managers
develop hiring plans commensurate with pipeline growth.
Partner with the CMO, Clinical Development, Clinical Operations and Regulatory Affairs to align biometrics strategy with overall program objectives.
Lead the design of clinical trials, including sample size determination, randomization, adaptive design methodology, and endpoint strategy.
Drive innovative approaches to trial design, such as seamless adaptive designs, and platform trials where appropriate.
Lead biometrics contributions to global regulatory submissions, including INDs, NDAs, BLAs, MAAs, and agency briefing documents.
Our Working Model: In Person, By Design
Connection: Face time matters. Building an enduring biotech company is about people, science, and strategy. Working side by side sharpens ideas, accelerates feedback, and fuels innovation for patients.
We believe diverse teams drive better science. We welcome applicants from all backgrounds and experiences who share our mission to bring transformative RNAi medicines to patients.

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.
Extensive experience with CDISC standards (CDASH, SDTM, ADaM) and regulatory submission requirements.
Exceptional communication skills with the ability to translate complex statistical concepts for non-statistical audiences.
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).
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.

The base salary range provided reflects our current estimate of what we anticipate paying for this position.
Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics.
In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
Pay range is $311,000 to $360,000

Define and execute the strategic vision for the Biometrics function, aligning capabilities with City Therapeutics' clinical development goals and pipeline priorities.
Represent City Therapeutics Biometrics in interactions with the FDA, EMA, and other health authorities; lead statistical discussions during regulatory meetings.

Face time matters.
Building an enduring biotech company is about people, science, and strategy.
Working side by side sharpens ideas, accelerates feedback, and fuels innovation for patients.

This listing is sourced directly from City Therapeutics's careers page and normalized into a canonical job model.