VP, Biostatistics — Oncology Strategy

Crescent Biopharma; Waltham (MA); Hybrid; USD 323,000 - 357,000; Full time

Benefits offered by this job

Competitive compensation

100% employer-paid benefits

Flexible PTO and company shutdowns

Professional development opportunities

Job summary

Crescent Biopharma is seeking a Vice President, Biostatistics to lead strategy and operations from our Waltham, MA office or remotely from the East Coast. You will build the team, set the statistical framework, and be accountable for the pipeline's statistical strategy from IND through BLA submission, with a focus on oncology programs.

You will oversee trial design, regulatory interactions with FDA/EMA, CRO management, and CDISC standards to ensure regulatory readiness while driving innovation

Qualifications

• Advanced degree (PhD preferred) in Biostatistics, Statistics, Data Science, or a related quantitative field.
• 15+ years of experience in clinical biostatistics, with significant oncology drug development.
• Experience supporting programs from IND to NDA/BLA submission and regulatory approval.
• Leadership and people management experience with cross-functional teams.
• Familiarity with CDISC SDTM/ADaM and regulatory standards.

Responsibilities

• Define and execute the biostatistics strategy, aligned with oncology clinical development objectives.
• Provide statistical leadership in design and execution of clinical trials, including registrational strategies.
• Build a high-performing team and establish SOPs, governance frameworks, and compliance.
• Drive innovation in statistical methods and analytics to improve decisions and speed.
• Lead design/review of protocols, including sample size, interim analyses, and randomization.
• Support regulatory readiness and CDISC data standards adherence.
• Represent biostatistics in cross-functional meetings with clinical, regulatory, and QA.
• Lead interactions with health authorities (FDA, EMA, PMDA) on regulatory reviews.
• Oversee CRO/vendor strategy, selection, oversight, and cost optimization.
• Build and retain a high-performing internal Biostatistics team; plan headcount to milestones.

Skills

Leadership

Cross-functional collaboration

Biostatistics expertise

Regulatory strategy

Vendor management

People management

Education

PhD in Biostatistics

Job description

Crescent Biopharma is seeking a Vice President, Biostatistics to lead strategy and operations from our Waltham, MA office or remotely from the East Coast. You will build the team, set the statistical framework, and be accountable for the pipeline's statistical strategy from IND through BLA submission, with a focus on oncology programs.

You will oversee trial design, regulatory interactions with FDA/EMA, CRO management, and CDISC standards to ensure regulatory readiness while driving innovation