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
$323,000 - $357,000 a year
Additional Description for Pay Transparency:The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company's savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation - Unlimited PTO; Sick time - 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave - 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits
