Provide executive leadership for biostatistics across the oncology pipeline, focusing on trial design, statistical strategy from IND through BLA, regulatory interactions, vendor/CRO oversight, team building, SOPs/governance, and CDISC-compliant data standards to support registrational programs.
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
We are seeking an experienced and strategic Vice President, Biostatistics. This role may be based in a hybrid capacity from our Waltham, MA office or remotely from the East Coast. 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. You will build the team, set the strategy, and be accountable for the statistical framework that supports our pipeline from IND through registration and BLA submission, with a strong emphasis on oncology drug development within a biotech environment. You will serve as the statistical voice of the organization — shaping the quantitative foundation of every program in our pipeline. This role is based in Waltham, MA and you must have experience in the oncology space.
Responsibilities
- Define and execute the biostatistics strategy, setting clear goals aligned with oncology clinical development objectives.
- 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.
- Serve as a core representative in cross-functional meetings, aligning biostatistics strategy with clinical development, regulatory affairs, and quality assurance.
- Lead interactions with health authorities (e.g., FDA, EMA, PMDA) to address statistical questions during regulatory reviews.
- Oversee CRO and vendor strategy, including vendor selection, relationship management, performance oversight, and cost optimization.
- 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.
Education & Experience
- Advanced degree (PhD preferred) in Biostatistics, Statistics, Data Science, or a related quantitative field.
- 15+ years of experience in clinical biostatistics, with significant experience in oncology drug development within biotech or biopharmaceutical companies.
- Demonstrated experience supporting clinical programs from IND through NDA/BLA submission and regulatory approval, including registrational trials.
- Prior experience leading or contributing to regulatory interactions and submissions with global health authorities, including FDA, NMPA, and EMA.
- Demonstrated leadership and people management experience with cross-functional teams.
- Familiarity with clinical data standards (e.g., CDISC SDTM/ADaM).
- Strong understanding of regulatory requirements and clinical development processes.
What We Offer
- Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
- Competitive compensation, including base salary, performance bonus, and equity
- 100% employer-paid benefits package
- Flexible PTO; also, two, one-week company-wide shutdowns each year
- A commitment to your professional development, with access to resources, mentorship, and growth opportunities
Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
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