Crescent Biopharma

Vice President, Biostatistics

Waltham, MA · Exec

Sponsorship not specified$323k-$357kDetected 13 days ago

Data ScienceStatisticsClinical TrialsFDA RegulatoryExperimental DesignLeadershipBiostatisticsRegulatory Affairs

About the role

For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
This role may be based in a hybrid capacity from our Waltham, MA office or remotely from the East Coast.
You will serve as the statistical voice of the organization - shaping the quantitative foundation of every program in our pipeline.

Provide statistical leadership in the design and execution of clinical trials across all stages of development, including registrational strategies.
Build a high-performing team and establish processes, SOPs, and governance frameworks to ensure efficiency, standardization, and compliance across the portfolio.
Drive innovation in statistical methods and analytics to improve decision-making and execution speed.
Lead the design and review of clinical protocols, including statistical considerations, sample size calculations, interim analyses, randomization approaches, and study design recommendations.
Ensure biostatistics activities support regulatory readiness, including adherence to CDISC and other regulatory standards.
Establish and maintain strong partnerships with external vendors and service providers to support clinical development objectives and operational excellence.
Build, recruit, and retain a high-performing internal Biostatistics team
manage headcount planning in alignment with pipeline milestones.
Build, recruit, and retain a high-performing internal Biostatistics team; manage headcount planning in alignment with pipeline milestones.
The Company's clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates.

15+ years of experience in clinical biostatistics, with significant experience in oncology drug development within biotech or biopharmaceutical companies.
Demonstrated leadership and people management experience with cross-functional teams.
Strong understanding of regulatory requirements and clinical development processes.
This role is based in Waltham, MA and you must have experience in the oncology space.

Advanced degree (PhD preferred) in Biostatistics, Statistics, Data Science, or a related quantitative field.

Crescent Biopharma's vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients.
Reporting to the Chief Medical Officer, you will provide executive leadership across biostatistics activities, with an initial focus on CR-001, a PD-1/VEGF bispecific antibody, our lead asset.
Lead interactions with health authorities (e.g., FDA, EMA, PMDA) to address statistical questions during regulatory reviews.
Education & Experience
Prior experience leading or contributing to regulatory interactions and submissions with global health authorities, including FDA, NMPA, and EMA.

We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected.
We are seeking an experienced and strategic Vice President, Biostatistics.

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